One Year Anniversary of Tobacco Control Act

In 2009 the United States Congress completed a long rumored expansion of Title 21.  This was manifested via the Family Smoking Prevention and Tobacco Control ACT (Tobacco Control ACT), which was codified into law last year (1).  This article will review the purpose of the ACT, reflect on the actions taken in the past year, and discuss future changes yet to be implemented.

The expansion to the Act was deemed necessary in light of the dangers to public health and safety posed by tobacco products:

Pertinent Health and Economic Facts Cited by Congress:

• “Tobacco causes over 400,000 deaths in the United States each year, and approximately 8,600,000 Americans have chronic illnesses related to smoking.” (1)

• 3,000-4,000 individuals begin smoking every day and 1,000 will become addicted. (1)

• “Reducing the use of tobacco by minors by 50 percent would prevent well over 10,000,000 of today’s children from becoming regular, daily smokers, saving over 3,000,000 of them from premature death due to tobacco-induced disease. Such a reduction in youth smoking would also result in approximately $75,000,000,000 in savings attributable to reduced health care costs.” (1)

Advertising’s Effect on Future Use:

• “In 2005, the cigarette manufacturers spent more than $13,000,000,000 to attract new users, retain current users, increase current consumption, and generate favorable long-term attitudes toward smoking and tobacco use.” (1)

• Tobacco product advertising is regularly seen by persons under the age of 18, included in sponsorship of sporting events, and is frequently seen in movies. (1)

• Most people begin smoking as minors and become addicted before the age of 18.  More than 80 percent of youth smoke three heavily marketed brands, while only 54 percent of adults, 26 and older, smoke these same brands. (1)

• The National Cancer Institute found that many smokers mistakenly believe that ‘‘low tar’’ and ‘‘light’’ cigarettes cause fewer health problems than other cigarettes even though research demonstrated that these products offer no reduction in health. (1)

The Tobacco Control Act was passed on June 22, 2010.  The objectives of the act were twofold:

1)    To regulate tobacco products and

2)    To mitigate issues of public health and safety concern. (1)

The Tobacco Control Act gives authority to the FDA to treat tobacco manufacturers as drug manufacturers, including the right to:

• set active ingredient standards

• require facility registrations, product approvals and listings

• specify the contents of health warning labels

• set and enforce manufacturing standards and controls

• inspect routine manufacturing and conduct post market surveillance activities, and

• review products that will increase the risk of tobacco use (e.g. additives). (13)

In the previous 12 months, the FDA has completed the following:

1)    Created and staffed the Center for Tobacco Products.  This program, under the director, Lawrence Deyton, an expert on veterans’ health issues, public health, tobacco use, and a clinical professor of medicine and health policy, will use science to implement public health strategies. (10)

2)    Created the tobacco user fee program.  (The Center is funded by user fees paid by manufacturers and importers of tobacco products.  The user fee program will generate over $4.5 billion in user fees over nine years which is available for FDA tobacco regulation support activities.) (12)

3)    Enforced the portion of the law that prevents manufacturing, distributing, and selling certain flavored cigarettes, such as spice-, fruit-, and candy-flavored cigarettes (7).  This included taking enforcement actions against manufacturers who continued to distribute flavored cigarettes.

4)    Assembled a Tobacco Products Scientific Advisory Committee (TPSAC) that will research various topics and report to Commissioner of Food and Drugs on health and other issues.  Currently the group is researching: (3)

• Products that are added to cigarettes that enhance the effects of nicotine in the brain.

• “Studies suggest that additional compounds in tobacco smoke, such as acetaldehyde, may enhance  nicotine’s effects on the brain.(3) A number of studies indicate that adolescents are especially vulnerable to these effects and may be more likely than adults to develop an addiction to tobacco.”

• Impact of menthol in cigarettes on the public health.  

• On July 15-16, 2010 the TPSAC held a meeting that discussed the effects of menthol on the public health.  Speakers from various tobacco companies, (e.g. Philip Morris, R.J. Reynolds and Lorillard) presented their research of menthol and all concluded that menthol had no statistically significant effect on health. (11)

5)    Begun processing facility registrations. (13)

6)    Assigned authorities to collect the following data from tobacco companies:

• Product lists

• Detailed information about product ingredients and manufacturing processes

• Company’s research into the health effects of their products (1)

   
7) Requested Philip Morris USA turn over its market research on consumer reaction to labeling changes in the Marlboro Lights product line. (5)  The Marlboro Lights brand name was changed to are Marlboro Gold as a result of Title 21s prohibition of using language on labels that implies a lower risk product, unless the lower risk could be clinically proven. (1)

8)    Authored the “Draft Guidance on Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.” (15)

9)    Authored a document providing guidance to manufacturers on the enforcement policy concerning rotational warning plans for smokeless tobacco products. (14)

10)    Authored a guidance document on questions related to the use of ‘light’, ‘mild’, ‘low’ or similar descriptors in the labeling, or advertising of tobacco products. (9)

11)    Authored the “Draft Guidance for Industry and FDA Staff: “Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.” (16)

In the previous 12 months, tobacco manufacturers have submitted to the FDA:

• A listing of ingredients and additives that are added to each tobacco product. (1)

• A description of the content, delivery, and form of nicotine in each tobacco product. (1)

• Documents that relate to health, toxicological, behavioral, or physiologic effects of tobacco products, their constituents, ingredients, components, and additives. (1)

• Research activities and findings on the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents. (1)

• Research activities and findings that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the employment of technology available or known to the manufacturer. (1)

• Marketing research about tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors. (1)

The specific portions of the law that have become effective in the previous 12 months include:

• The prohibition of any cigarette component from containing any artificial or natural flavoring (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla,  coconut, licorice, cocoa, chocolate, cherry, or coffee. (1)

• The prohibition of:

• the sale of cigarettes and smokeless tobacco products to youths younger than 18 and requires photographic age verification to sell these products to individuals 26 years and younger

• the sale of cigarette packages with fewer than 20 cigarettes

• the sale of cigarette packages and smokeless tobacco in vending machines, self-service displays, or other impersonal sales mechanisms, except where no one under the age of 18 is present or permitted

• free samples of cigarettes and smokeless tobacco products, except in adult-only establishments

• tobacco brand-name sponsorship of any athletic, musical or other social or cultural event, or any team or entry in those events

• using a trade or brand name of a non-tobacco product for a cigarette or smokeless tobacco product, unless the name was so used on 1 January 1995

• gifts or other items in exchange for buying cigarettes or smokeless tobacco products

• the sale or distribution of items, such as hats and T-shirts, with tobacco brands or logos but permits sponsorship in a corporate name

• the use of music and sound effects in audio (6)

• the advertising or labeling of tobacco products with the descriptors “light,” “mild,” or “low” or similar descriptors without FDA approval of the label claim (1)

• Require new, larger health warning rotational labels for smokeless tobacco products begin to rotate on labels, such as:

• WARNING: Cigarettes are addictive.

• WARNING: Tobacco smoke can harm your children.

• WARNING: Cigarettes cause fatal lung disease.

• WARNING: Cigarettes cause cancer.

• WARNING: Cigarettes cause strokes and heart disease.

• WARNING: Smoking during pregnancy can harm your baby.

• WARNING: Smoking can kill you.

• WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. (1)

The full force and effect of the expansion to Title 21 has not yet been realized.  Future activities include, but are not limited to:

• Jan 2011 – A group of experts will be created by the FDA to create a document for Congress, due July 2013, that will examine how best to regulate, promote, and encourage the development of innovative products and treatments to help public health based on abstinence and  reducing consumption of tobacco (1)

• Jan 2011 – Stricter regulations will be released regarding the sale and distribution of tobacco products that occur through means other than a direct, face-to-face exchange in order to prevent purchase by minors (1)

• July 2011 - A tobacco product manufacturer will no longer be able to use tobacco that contains a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco. (1)

• July 2012 – 2014 –Testing and reporting of tobacco product constituents, ingredients, and additives that the Secretary determines should be tested to protect the public health.

• July 2012 – 2014 –The Secretary will enforce regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product conform to current good manufacturing practice, or hazard analysis and critical control point methodology.

• Based on the above regulation, tobacco companies will need to establish Quality Systems in order to ensure compliance.  (21 CFR 820 Quality System Regulation (GMP—Good Manufacturing Process).  The following components of Quality Systems will need to developed:

• Quality By Design and Product/Process Development

• Risk Management

• Quality System Training

• CAPA Programs

• Material Control, Component Control, and Lot Release

• Change Control

• Management Training

• Quality Audits

• New product registration (1)

Within the past year there has been significant progress on the goals of the new regulations.  Margaret Hamburg, Commissioner of the FDA, acknowledges the progress, but notes that there is much more work ahead, “As we complete our first year executing this important new responsibility, FDA has much to be proud of and much yet to do to improve public health through effective tobacco regulation.” (13)

Much of the progress reported within this blog reflects activity on the Federal Level, and has been made public by the FDA.  As industrial progress becomes more visible, we will endeavor to track and report it in subsequent postings.

It is critical to note that the challenges posed to industry by these regulations are significant; constructing a corporate infrastructure designed to interact with FDA and meet the definitions of modern Quality Systems cannot be achieved overnight.  The act of constructing these systems, while maintaining corporate supply chains, represents complex change and extraordinary evolution of corporate culture.

All of us at Coda Corp USA and our blog followers may never before have had the opportunity to witness such large scale change enfold.  We all understand the magnitude of change required by the expansion of Title 21, fully support this new collaboration, and wish all involved patience and success during this time of change.

© Coda Corp USA 2010.  All rights reserved.
__________________________
Authors:
Corrine R. Knight & Gina Guido-Redden
Coda Corp USA

www.CodaCorpUSA.com

References
1)    http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ031.111.pdf
2)    http://www.drugabuse.gov/infofacts/tobacco.html
3)    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180109.htm
4)    http://tobaccoreporter.com/home.php?id=498&art=3483
5)    http://www.businessweek.com/magazine/content/10_27/b4185014579409.htm?campaign_id=rss_null
6)    http://www.tobaccojournal.com/index.php?id=50051
7)    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm183211.htm
8)    http://tobaccoreporter.com/home.php?id=498&art=3541
9)    http://tobaccoreporter.com/home.php?id=498&art=3466
10)    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179410.htm
11)    http://www.capitolconnection.net/capcon/fda/fda071510_launch.htm#
12)    http://www.fda.gov/ForIndustry/UserFees/TobaccoProductFees/default.htm
13)    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216406.htm
14)    http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214474.htm
15)    http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214425.htm
16)    http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214598.htm
17)    (Title 21, Chapter IX, Section 915 (b1)
18)    (Title 21, Chapter IX, Section 906 (e1)

FDA: Improving Strategy for Ensuring Integrity of Clinical Data

Clinical data management is generally understood to mean a process of implementing a reliable method for collecting, processing, managing, and conveying data in a manner that protects subjects’ rights, and insures data integrity.  Historically, regulations intended to ensure the integrity of clinical data are contained within 21 CFR 312.

The ability to falsify data is far greater in clinical studies than in routine production, due to the nature of this data:

•    access to it is far more open than post market data
•    the interpretation of the meaning of data is common, as opposed to the clear
-    measurements against specified limits taken during routine production

Falsification of data includes creating, altering, recording, or omitting data in such a way that the data no longer represents what actually occurred.

Examples of falsification of data include but are not limited to:
•    creation of data points that were never obtained
•    alteration of data points that were obtained by substituting different data
•    recording or obtaining data from a specimen, sample or test whose origin is not
-    accurately described or in a way that does not accurately reflect the data
•    omission of data points that were obtained and ordinarily would have been recorded

Falsification of clinical data can have extremely dangerous consequences, including placing all subjects in that trial at possible safety risk.  Falsification also jeopardizes the reliability of data submitted and/or published and undermines FDA’s mission to protect and promote the public health.

The criticality of clinical data integrity was well known to the regulating body and the regulations contained within 12 CFR 312.62, .64, .66 and .68 were developed in an attempt to mitigate that risk.  The extent to which these regulations can protect the integrity of data is limited when compared to similar regulations for post market data.

Post market data management regulations and practices were designed to promote the integrity of data that can be specified and predicted.  These types of regulations are designed to control and demonstrate integrity as well as accuracy.  However, clinical data is generated during research phases, and therefore cannot be specified.  This type of data is generated to inform, rather than to confirm.

The regulations concerning the management of clinical data were designed to focus on confirmation of accuracy, and not on integrity.  It is critical to note that the regulators were aware of the inability to predict data at this point in research and therefore regulations designed to associate legal responsibility for the integrity of clinical data were developed and are contained within 21 CFR 312.70.

The scope of 312.70 is limited to Clinical Investigators, formally assigning legal responsibility to those individuals most directly responsible for the generation and protection of clinical data.

The authority granted in 312.70 however, could only be utilized (triggering penal enforcement actions) if falsification was discovered.  The process of approving new drug applications and investigational applications includes a data review by the FDA.  In post market situations, FDA can use past experiences with the manufacturer and the drug/device to target inspections in such a way as to pre-define high risk areas.

As every data set submitted during the investigational phase is new to the agency, utilizing historic experiences with the product was not possible, so another mechanism for determining high risk areas needed to be developed.  Toward that end, regulators decided to determine risk by motivation of the researchers.

As such, the clinical regulations were supplemented by new regulations in 1999 that were intended to ensure that any financial interests of clinical investigators that might have the ability to affect the reliability of data were classified and fully disclosed to the government.

This expansion of the regulations was considered necessary as many forms of compensation provided to clinical investigators at that time created a situation that could incentivize the falsification of data.

These types of situations included:
•    Compensation made to the clinical investigator in which the value of the
-    compensation could be affected by the study outcome
•    a proprietary interest by the investigator in the tested product, such as a patent
•    a significant equity interest in the sponsor of the covered study
•    significant payments by the sponsor of the covered study of other sorts, such as
-    a grant to fund ongoing research, compensation in the form of equipment, or
-    retainers for ongoing consultation or honoraria

The general response to this action (communicated during public meetings) from the manufacturing and clinical populations voiced support for efforts to reduce the likelihood of any financial arrangements that had the potential to bias the quality of clinical data.

Under this rule, if any clinical investigator was compensated in any way that could lessen their objectivity, the scrutiny with which their data sets were reviewed would be increased.

In a continuing effort to reduce situations that could incentivize the falsification of clinical data, the FDA is now focusing on the role of drug and device sponsors.  Toward that end, the FDA has recently submitted a proposed rule that requires the study sponsor to report any suspected falsification of clinical data within 45 days of issue identification.  The FDA is hoping, as the sponsor is in a unique position to internally monitor data collection, that regulations formally requiring them to report their findings will contribute to the integrity of clinical data.

However, these regulations continue to deal with the issue after falsification has occurred.  This in the opinion of these authors does not directly promote the quality of data generated.  It does seek to lessen the motivation to falsify data.

Holding everyone involved responsible for any action that has the potential to harm the public is clearly fair and just.  However, penalty options are not generally effective deterrents, if the financial incentive to falsify data remains greater than the potential financial penalty if discovered.

Evidence supporting this opinion is generated with almost every routine inspection of modern manufacturing plants.  The financial incentive while a drug or device is in the clinical phase is as great, if not greater than a drug in the post marketing phase.

Financial motivation is clear.

The flexibility that can be built into a clinical study also provides opportunities for types of data falsification that is difficult to detect, and non-routine methods of reporting the data allow for further opportunity to mis-state or misuse data.  The non-routine nature of the collected data, and the reporting techniques, also considerably amplify the review challenges presented to FDA.

Opportunity and means are also clear.

Consider the following as an example of the dangers that can be posed in light of the flexibility of clinical study data collection and interpretation mechanisms:

Company A manufacturers a drug that has been proven to increase suicidal thoughts in children.  A fraud lawsuit against the company in 2004 claimed that three of five clinical trials verified that suicide-related behaviors were observed twice as often among young subjects given the active drug as those that were given the placebo. While an application for use for children was never filed; doctors have professional discretion to prescribe the drug for any group that is not contraindicated.

The suit claimed that the company delayed submitting the test results to government regulators for years and chose not to include the information contraindicating pediatric use in the “Medical Information Letters” sent to doctors.  Without this warning, doctors prescribed the drug as they felt warranted.  The company did not admit to guilt but later settled and agreed to pay more than $70 million to 6 states and to Medicaid.

This company is currently conducting a pediatric trial in Japan The nature of the trial design does not include a focus on links to suicidal behavior  which will allow any observed link to suicide behaviors to also go unreported or under-emphasized.

Given this example, it is clear, that the clinical investigators are not the only players in the game that may be incentivized or have an opportunity to falsify or misuse clinical data.  In this case, the investigator may have failed to highlight the findings, but the sponsor must have realized the significance of the data, as the resultant application did not include pediatric usage.  The sponsor also chose to completely omit this information from subsequent communications with the medical community.

This example is not unique.

The greatest impact these proposed regulations could have is if they encourage sponsors to develop and implement robust data monitoring systems.  If these systems are not developed and implemented, then the effect of this regulation will be limited to expansion of the scope of individuals and/or organizations that can be legally penalized once fraudulent activity has been discovered.

While we sincerely hope that the new reporting regulations encourage sponsors to establish and implement more robust collection and monitoring systems, we also believe that requiring the implementation of these enhanced systems is a step that should be strongly considered.

It is clear that the nature of clinical investigation will always require the ability to design unique protocols, and to interpretively report data, it also seems clear that building systems that can provide effective oversight in real time is also possible.  If it is not practical for industry to provide this oversight in real time, perhaps the nature of the FDA’s involvement during clinical trials should be modified in order to allow more effective federal oversight.

We will continue to monitor progress in this area and report it to our readers.

Stay tuned…

© Coda Corp USA 2009.  All rights reserved.
__________________________
Authors:
Corrine R. Knight and Gina Guido-Redden
Coda Corp USA

www.CodaCorpUSA.com



References
Financial Disclosures by Clinical Investigators: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm119145.htmReporting Information Regarding Falsification of Data: http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdfhttp://industry.bnet.com/pharma/10008290/glaxo-is-testing-paxil-on-7-year-olds-despite-well-known-suicide-risks/http://www.fda.gov/RegulatoryInformation/Guidances/ucm126832.htm
http://www.consumeraffairs.com/news04/paxil_ny.html

Gulf Spill, Industrial or Governmental Failure?

In the last few weeks (57 days) an overwhelming amount of information has been pouring into the media with regard to British Petroleum’s deep water rig explosion. As a Quality Systems professional, whose job it is to assure the control of processes and the eventual outcome of them, I wanted to do my own research into the cause of this catastrophic failure.

The more I researched, the more apparent it became to me, that the system failures included non-existent Risk Management, inefficient Change Management, and ineffective regulatory oversight.

I began by researching the documented evidence of milestones on the path to this event, and organized them by date for my own understanding, just as I, and any Quality professional would have done in a routine problem investigation. 

As I do not have access to British Petroleum's standard operating procedures, or any records following them may have produced, my research was limited to documents currently available to the public.

The following is a list of relevant findings. 

1995: The Outer Continental Shelf Deepwater Royalty Relief Act

Signed into law by President Clinton, this act exempted oil wells drilled in deep water from the mandated royalty payments averaging at the time to amounts between 12% and 16% of revenues. Beyond a predictable effect, this Act was intended to incentivize drilling in deep waters in the Gulf of Mexico.

Predictably, deepwater oil production in the Gulf increased rapidly; annually 42 million barrels in 1996 to 348 million in 2004 (6% of total United States oil consumption and 15% of domestic production). Over the same period, natural gas production from deep water Gulf drilling increased tenfold.

The Deepwater Horizon, drilling since 2001 and currently leaking uncontrollably in the Gulf was one of those created as a result of this governmental action.

The legislation was heavily supported by Congressional Republicans and Democrats in Congress, particularly those representing the Gulf States.

Incentivizing deep water drilling was designed to reduce America’s dependence on foreign oil. Many politicians, economists and industrialists continue to agree, that deep water domestic drilling was and remains fundamentally critical to maintaining a healthy economy, and bridging the gap between short and long term energy plans.


Risk Management Regulations

By this time, Risk Mitigation programs were already required components of almost all regulated industries, including pharma and energy. These industrial policies and strategies are critical steps in Quality Change Management. In every industry, regulated or not, some level of Risk Management is employed, if for no other reason, than to optimize the chances of planned success and reduce the impact of unintended consequences of change.

In almost every federally regulated environment, Risk Management is not only practiced, but required, and presumably, the resultant mitigation plans are scrutinized by regulators. Shockingly, that does not appear to have been the case with deep water drilling.

It is clear at this point, that the Clinton Administration – and the Bush and Obama Administrations that followed failed to either consider risk, or require evidence of Risk Management activities within the industry, prior to monetarily incentivizing large scale change.

This stands in stark contrast to the licensing of nuclear power plants. When dealing with the production of nuclear energy, enormous amounts of time and money have been spent studying and identifying potential failure modes and developing appropriate fail safe systems.

It appears in this case, that there were no failure mode effect studies performed, as the technology in place was incapable of preventing an explosion, or stoping the flow of oil, or preventing the oil from reaching the shores, should the explosion occur. Generally, failure mode effect analysis (FMEA) takes into account the magnitude of severity and the likelihood of occurrence when rating risk. In a case of such an enormous and obvious severity, most modern industrialists would have expected a mitigation plan with several layers of redundancy.


2000: Report Regarding a Shell Oil Offshore Drilling Plan Submitted for Approval to the Interior Department’s Minerals Management Service

Skip forward five years (a decade ago), as noted in a report responding to a drilling plan for Shell Oil, Federal regulators warned that “a major deep water oil spill could start with a fire on a drilling rig, prove hard to stop and cause extensive damage to fish eggs and wetlands because there are few good ways to capture oil underwater.”

The author of the document was the Interior Department’s Minerals Management Service (MMS), the regulatory agency that has come under criticism in the wake of today’s reality in the Gulf of Mexico.

According to experts and former MMS officials (as reported by McClatchy Newspapers) the 2000 warning indicated that Federal regulators were well aware of the potential hazards of deep water oil production in its early years.

The Shell plan (which Greenwire, an environmental news service, first reported last week) described a worst-case scenario for a deep water blowout that reads like a real time description of what has happened since the deep water Horizon rig exploded.

While noting a major blowout was very unlikely, the report to the Shell plan said, “Regaining well control in deep water may be a problem since it could require the operator to cap and control well flow at the seabed in greater water depths … and could require simultaneous firefighting efforts at the surface.”

The 2000 Shell plan also cautioned that an oil gusher wouldn’t behave the same way in deep water as one would in shallow water, where most drilling to that point had been done. “I think the industry was certainly overwhelmed by the excitement of all the oil and gas that was starting to show up in the seismic studies and the technical excitement of how to drill these reservoirs,” said Rick Steiner, a veteran environmental scientist who reviewed the document for McClatchy News.

“I think that had a way of subduing the real concern about the risk of these things.”
The Report continued, “Spills in deep water may be larger due to the high production rates associated with deep water wells and the length of time it could take to stop the source of pollution.”

This report was issued for a Shell site less than 140 miles southwest of the deep water Horizon, and included the following warnings:

• The chemical dispersants required to clean up a major spill would expose adult birds to a combination of oil and dispersant that could “reduce chick survival”.

• “Fish eggs and larvae within a potentially large area of the northern Gulf would be killed.”

• In certain weather and oceanographic conditions, a large blowout could have “severe adverse impacts” for wetland areas.

• Not all the spilled oil would rise to the surface, and “there are few practical spill response options for dealing with submerged oil.”

• Gas surging from a blowout could form hydrates and remain deep underwater (a likely cause of some toxic subsea oil plumes that scientists have identified in the BP spill).

Dennis Chew, a marine biologist who helped prepare the report but has since retired after 21 years with the MMS, studied it again this week and said, “Bottom line, [the BP] blowout was preventable.”

Chew and two other members of the team that prepared the Shell plan said MMS scientists analyzed the potential impact of deepwater blowouts as far back as the late 1990s. “10 or 15 years ago, there used to be 200-page [environmental impact statement] on nothing but spills,” Chew said. “It got to where people got tired of wading through them.”

The 2000s, however, ushered in an era of aggressive, government-backed offshore oil production.


2001: Executive Order Expediting Energy Product Permits

In May 2001, Bush, acting on recommendations from the oil industry, signed an executive order that required federal agencies to expedite permits for energy projects and paved the way for greater domestic oil exploration. The rush to drill in deep water swept aside warnings from MMS scientists and others, experts said.


Blame, Industry or Government?

“It’s the fault of both the industry and the government,” Steiner said. “If they had taken it seriously, they would have been ramping up production of safer blowout preventers and emergency procedures on board. They would have said, ‘There’s a 0.01% chance of this, but that’s enough for us because this would be catastrophic.’”

Criticism of the agency that manages offshore drilling on the outer continental shelf includes obvious claims of conflict of interest as the agency generates revenue from active drilling leases. Since the BP explosion, the agency director, Elizabeth Birnbaum, has resigned and Obama administration officials have said the agency will be divided into three branches to avoid future conflicts of interest.

In the recent past, the MMS under the Obama administration had approved dozens of new deepwater exploration plans the administration has since ordered oil companies to resubmit the plans with additional safety information before the government would allow them to drill new wells.

Public Employees for Environmental Responsibility, a watchdog group, reported last month that BP’s spill response plan erroneously listed seals and walruses as “sensitive biological resources” in the Gulf—suggesting that portions of BP’s plan were cut and pasted from Arctic exploratory documents. The plan also cited a Japanese home shopping website as one of its primary equipment providers.

Steiner found flaws in the 2000 Shell plan, too. It offered optimistic projections of the possibility of a deep water blowout being bridged—or naturally sealed—by sliding rock on the seafloor. It also said a blowout from exploratory drilling would last only two days, supposedly due to bridging. “This plan, like all of them, underestimates risk and overestimates the effectiveness of the response,” Steiner said.


Summary

During my research for this blog entry, it became very clear that both the regulators and industry were aware of:

• the dangers of deep water drilling

• the value of the standard concepts of Risk Management and Change Management

• the lack of risk mitigation plans in the deep water environment


These are failures of modern Quality Systems.

Where does this leave us?

With an understanding that a free market does exactly what a free market was designed to do, respond to demand, as quickly, and as competitively as possible.

This is the free market.

The risk mitigation to a free market, in our system, was supposed to be oversight at the Federal level, whose single objective, and only mandate, is the protection of our environment, and our safety.

This is regulatory oversight.

It seems clear to me that somewhere along the way, the federal agency providing the oversight became tied to revenue generation, which in turn, made them a cog in the machinery that is the free market.

Everyone was focused on profit, no one was focused on safety, the result, was both predictable and avoidable.

The private sector, in competition for consumers, has a board of directors, executives and shareholders that will assure that processes are evaluated for the future, and they will correct in order to prevent. This is their future path to continued profit.

This is economics.

But who will insist that the oversight program is corrected, in order to prevent recurrence? Who will investigate that system failure, and make the results known to the voters? The only people that could identify and correct are those people seeking re-election and re-appointment. Evaluating the failure is not their path to future profit.

This is politics.

We may be removed from the detailed information, but we have the ability to examine the past and to draw conclusions on our own. We still have the power to voice our concern when we vote. We still have the power to be actively involved in the nature or our representatives.

This is democracy.

This is a mighty power.

Use it.
__________________________________________________________________________
Author:
Gina Guido-Redden
Chief Technical Officer
Coda Corp USA
(p) 716.751.6150
GGuidoredden@CodaCorpUSA.com
http://www.codacorpusa.com/

"Quality is never an accident; it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives."

The USFDA Launches Initiative to Reduce Infusion Pump Safety Risks

The U.S. Food and Drug Administration has announced a new initiative to address what FDA’s Center for Devices and Radiological Health (CDRH) has referred to as “rampant” safety issues associated with the technology utilized by external infusion pumps. CDRH Director Jeffrey Shuren has called this a first for the agency, exercising its authority over an entire class of devices. The initiative involves launching a proactive model of industry involvement which seeks to set and publically define the bar for the design, manufacture and control of infusion pumps.

Infusion pumps are widely used in hospitals, other clinical settings, and the home. The devices are intended to allow a greater level of control, accuracy, and precision in drug delivery, and help to reduce medication errors.

Shuren continued by stating that, “these pumps often provide critical fluids to high-risk patients, so failures have significant implications. It is time for a more comprehensive approach than we’ve taken to date.”

FDA reports that up until this point in time, their practice has been to deal with pump issues on a case by case basis, but sobering figures between 2004 and 2009 have prompted the agency to alter their practice. These figures include;

· 87 safety based recalls

· 56,000 reportable adverse events

· More than 500 patient deaths

The Initiative White Paper issued by FDA describes the broad based actions that FDA intends to take in order to offer increased patient protection, including;

1. The establishment of additional and specific requirements for pump manufacturers

2. The proactive facilitation of device improvements

3. The advancement of user awareness

This comprehensive and ground breaking initiative will include, but may not be limited to the following;

· An initiative white paper

· A letter to pump manufacturers

· A new and exceedingly specific guidance document

· Updated inspection manuals

· A pump specific web site and

· A public meeting to be held in May 2010

Reported problems have most commonly been related to:

• software defects, including failures of built-in safety alarms
• user interface issues, such as ambiguous on-screen instructions that lead to dosing and user errors; and
• mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires
• incomplete MDRs
• an inability to indentify exactly how many pump units were actually in use, which leads to an inability precise rates of adverse effects

Failures of infusion pumps have been observed across multiple manufacturers and pump types. The FDA says that many of the reported problems appear to be related to deficiencies in device design, engineering, validation and usability.

Draft Guidance Document;

As part of its initiative, FDA is moving to establish additional premarket requirements for infusion pumps, in part through issuance of a new draft guidance for infusion pump manufacturing and control. The guidance also requires that infusion pump manufacturers provide additional design and engineering information to the agency during premarket review of the devices.

Among other things, the new guidance instructs manufacturers to;

· Include in their 510(k) applications and explanation of the steps they have taken to reduce the risk of their devices at each stage of the life cycle, from design to actual operation

· Test pumps in the environment of routine use, which includes including clinical environments in validation testing, defining the worst case scenario as those that include real-life use conditions, including inexperienced users

· Be prepared for the agency to withhold 510(k) approvals until manufacturing facilities specific to each pump have been inspected

Letter to Manufacturers;

The FDA also issued a letter to infusion pump manufacturers, informing them that they may need to conduct additional risk assessments to support clearance of new or modified pumps.

In addition to alerting manufacturing of this intended change, the letter offers manufacturers the option of submitting their infusion pump software codes to experts at the FDA for static analysis prior to premarket review. Static analysis is a diagnostic technique that can help detect software problems early in the device development process. The agency previously invited manufacturers to make use of an open-source software safety model developed through the Generic Infusion Pump project, an ongoing collaboration with outside researchers aimed at improving pump design.

Public Meeting;

FDA is also hosting public meeting on infusion pump design, and launching a new Web page devoted to infusion pump safety.

The FDA’s public workshop will be held May 25-26, 2010. Participants will discuss observed safety problems, and explore opportunities to work with others, including foreign regulators, to improve the design of infusion pumps on the market or in development, in order to reduce pump malfunctions and errors.

“Working with industry and users, we can help develop safer, more effective infusion pumps and improve patient care” said Shuren.

The public meeting is limited to 300 attendees, but may be viewed online (see reference section) for up to 30 days after video posting. The meeting is expected to include at least some contention from manufacturers, as public from manufacturers were quickly issued.

Pump Web Site;

The agency’s new infusion pump safety Web page features basic information about infusion pumps and steps that patients and healthcare professionals can take to prevent and report safety problems, even before new or redesigned pumps are brought to the market.

Advice to Clinicians;

To help reduce infusion pump risks, the FDA asks clinicians to consider the following general strategies.

• Plan ahead and be ready to respond in the event of a pump failure
• Label infusion pump channels and tubing to prevent errors
• Check infusion pump settings and monitor patients for signs of over- or under-infusion
• Use available resources to prevent and respond to pump problems
• Report adverse events promptly to the FDA

© Coda Corp USA 2010. All rights reserved.

____________________________________
Author
Gina Guido-Redden
Chief Technical Officer
Coda Corp USA
(p) 716.751.6150
GGuidoredden@CodaCorpUSA.com
http://www.codacorpusa.com/

"Quality is never an accident; it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives."

For more information:

• Letter to Infusion Pump Manufacturers
• Center for Devices and Radiological Health information on infusion pumps.
• White Paper: Infusion Pump Improvement Initiative
• USFDA Guidance Document, Total Product Lifecycle: Infusion Pump Pre-Market Notification [510(k)] Submissions
• Public Meeting: Infusion Pump Workshop, May 25-26, 2010
• Federal Register: Infusion Pumps; Public Meeting; Request for Comments
• Generic Infusion Pump Project
• Examples of Reported Infusion Pump Issues
• USFDA Infusion Pump Software Safety Research
• Infusion Pump Risk Reduction Strategies
• Report An Infusion Pump Problem

Media Inquiries:

Dick Thompson, 301 796 7566; dick.thompson@fda.hhs.gov

Consumer Inquiries:

888-INFO-FDA

FDA Launches Initiative to Provide Oversight to Home Use Medical Devices

The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home.

The FDA hopes that The Home Use Initiative will help address the potential challenges, by providing greater protection and awareness for patients who are being cared for in the home.

A home use device is a medical device intended for users in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for the user, and may require training for the user by a licensed health care provider in order to be used safely and effectively.

“Medical device home use is becoming an increasingly important public health issue,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

The U.S. population is aging, and more people are living longer with chronic diseases that require home care, he said, adding that “more patients of all ages are being discharged from the hospital to continue their care at home.”

Changes in health care have moved care from the hospital environment to the home environment. In fact, according to results of the 2000 National Home and Hospice Care Survey “approximately 1,355,300 patients were receiving home health care services from 7,200 agencies.” In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually.

The portable nature of modern medical devices enables wide spread use in the homes of patients. Devices commonly seen in homes today include including infusion pumps, ventilators, wound-care therapies, dialysis equipment, and intravenous therapy devices.

Using complex medical devices at home carries unique challenges. Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product’s functioning. Environmental considerations and potential safety hazards providers and patients should be alert to when using – or considering using – a medical device in the home setting include;

· Geographic Location

· Age and Structure of a Home

· In-Home Environmental Hazards

· Pets

· Unsanitary Conditions

· Children at Play

· Plumbing

· Temperature Extremes

· Dust

· Fire Hazards

· Tripping Hazards

· Poor Lighting

· Background Noise

The agency has already received reports adverse events linked to medical devices in the home. “And due to widespread underreporting, it is likely just the tip of the iceberg,” Shuren said. For example, a dialysis machine became blocked by cat dander and would not function, he said. In another case, a ventilator whose alarm could not be heard in the home caused the ventilator to fail, resulting in injury and death.

To deal with these problems the agency plans to develop recommendations for approval of these devices, including testing with home caregivers and patients, enhance the FDA’s authority to require that certain devices are labeled as cleared for home use and develop post-market procedures to track and address adverse events in the home.

The FDA is already citing manufacturers on potential trouble from at-home devices. On Monday, the agency sent letters to makers of negative-pressure wound therapy devices indicating they will need to start testing their devices specifically for home use and labeling them accordingly or stating the device is not for home use, Shuren said.

“By providing greater assurance of the safety and safe use of medical devices in the home, FDA hopes to support the tremendous promise of home healthcare to provide patients with more comfort, convenience and independence in their medical care,” he said.

Currently, the FDA does not have a clear regulatory pathway for devices intended for home use that describes the unique factors that manufacturers should take into consideration when designing, testing, and labeling such products.

The new home use guidance document is being developed to;

• Make recommendations for actions manufacturers should take to support premarket approval or clearance of these devices, including device testing with at-home caregivers and patients in a non-clinical setting
• Define circumstances under which the FDA may exercise its authority to require that certain devices cleared for marketing carry a statement in the labeling that the device has not been cleared for use in the home
• Recommend post market surveillance to identify and address adverse events that may occur in the home.

In addition to developing the guidance document, the FDA will launch a 10-month pilot program beginning in the summer of 2010 in which manufacturers of home use devices may voluntarily submit their labeling to the agency for posting on a central Web site repository. Posting medical device labeling in the repository will help home care patients and caregivers to quickly and conveniently access important information about the safe use of their devices.

The Home Use Initiative also contains measures for enhanced post market surveillance through HomeNet, a subnetwork of the FDA’s Medical Device Surveillance Network, an adverse event reporting program that includes more than 350 health care facilities nationwide.

Compiling Adverse Event data is not a new tool utilized by FDA. Adverse Event reporting is a current requirement under Title 21 for all non-home use devices, and drug therapies. This data is used not only to provide oversight on a case by case basis, but is also used to provide a mechanism for understanding issues experienced by the market place in general, and to identify meaningful trends.

The FDA is partnering with the Community Health Accreditation Program and the Joint Commission, which evaluates and accredits 17,000 U.S. health care organizations and programs, to strengthen home health agency accreditation criteria that relate to medical device safe use practices.

For additional information about the Medical Device Home Use Initiative, visit these resources:

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Initiative: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM209056.pdf

Press Release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209138.htm

Medical Device Home Use Initiative - White Paper: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM209056.pdf

Public Workshop Notice: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm205804.htm

Improving Patient Safety by Reporting Problems with Medical Devices Used in the Home – December 9, 2009: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm205691.htm

Improving Patient Safety by Reporting Problems with Medical Devices – Home Version: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm205434.htm

Brochure - Home Healthcare Medical Devices: A Checklist: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070217.htm

Home Healthcare Medical Devices: Blood Glucose Meters - Getting the Most Out of Your Meter: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070212.htm

Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ucm070208.htm

Home Health Quality Initiatives (Centers for Medicare & Medicaid Services): http://www.cms.hhs.gov/HomeHealthQualityInits/

Telehealth (Health Resources and Services Administration): http://www.hrsa.gov/telehealth/

Patient Safety (Department of Veterans Affairs): http://www.patientsafety.gov/patients.html

Assistive Technology (Administration on Aging): http://www.aoa.gov/AoAroot/Press_Room/Products_Materials/fact/pdf/Assistive_Technology.pdf

A Patient Safety Threat - Syringe Reuse (Centers for Disease Control and Prevention): http://www.cdc.gov/ncidod/dhqp/PS_SyringeReuseFS.html

Patient Safety Resource Center (Healthcare Technology Foundation): http://www.acce-htf.org/patient.asp

American Association for Homecare: http://www.aahomecare.org/

American Telemedicine Association: http://www.americantelemed.org/i4a/pages/index.cfm?pageid=1

National Association for Home Care & Hospice: http://www.nahc.org/

National Family Caregivers Association: http://www.nfcacares.org/caregiving_resources/

Joint Commission - National Patient Safety Goals: http://www.jointcommission.org/patientsafety/nationalpatientsafetygoals/

Assistive Technology Devices: http://resna.org/resnaresources/resources-%E2%80%93-at-devices

Joint Commission Resources - Home Care: http://www.jcrinc.com/Joint-Commission-Requirements/Home-Care/

National Patient Safety Foundation: http://www.npsf.org/paf/

____________________________________
Gina Guido-Redden
Chief Technical Officer
Coda Corp USA
(p) 716.751.6150 (f) 716.751.6193
GGuidoredden@CodaCorpUSA.com

http://www.codacorpusa.com/

"Quality is never an accident; it is the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wisest of many alternatives."