Patients Come First

It is a distracting time for the biopharmaceutical and medical device industries. Everyone is scrambling to gain advantage in the Senate health reform negotiations. Two major pharmaceutical companies disappeared in mega-mergers last week. Reportedly, more medical product companies are working on settlements with the Department of Justice.

All this frenzy makes it a good time to stop, draw a breath and remember why seriously-ill patients care about the success of biopharmaceutical and medical device companies.

Medical products—drugs, biologics, devices—are the hope of millions of Americans who are in ill health, disabled, or face the prospect of chronic disease. Patients want relief from symptoms, reduction in pain, the slowing of chronic disease and fewer restrictions on their ability to think, communicate and manage their own lives.

Who can deliver this? NIH research is essential to the advancement of biomedical science. But it is industry that creates the products for FDA to review for safety and efficacy. Take the companies out of the equation and you have nothing.

For this reason, seriously-ill patients need the biopharmaceutical and medical device industries just as much as industry needs patients. They share a common mission and a pressing need to improve public and individual health. It should be basis for a stronger alliance than exists today.

To unlock this additional potential, industry needs to rise above the many distractions that are unrelated to the needs of patients. Patients don't care which company bought another company, what US Attorney is announcing a lawsuit today, or whether there is a regulatory pathway for follow-on-biologics. Seriously-ill patients want innovations that provide relief and cures and they want to be able to manage their own care.

FDA's two hearings this week--one on risk communications and the other on the use of social media in medical product promotion--provide a timely example. Patients want reliable information in a context they can understand. They would like to be informed without being scared by long lists of unlikely side-effects. Patients want their doctors to be knowledgeable and don't really care how their doctors received truthful, medically-useful information.

In short, patients are not interested in communications that elevate structure over content, coherence or accessibility.

Arguably, this is an area where industry let itself become distracted by its battle with FDA on marketing issues. An earlier resolution might have been possible if a patient-centric approach had been advanced, rather than a commercial one.

Most seriously-ill patients wake each morning wondering how they will surmount the day's challenges. They are concerned about the health of all Americans, but can't help being focused upon their own medical situation. Most of the people I know in the medical products industry wake each morning with the hope that their day's efforts can contribute to improving the health of all Americans, as well as provide specific benefits to seriously-ill patients.

The world-views of patients and industry are not dissimilar. They can share a dream (and an action plan)…if it is built on an unwavering commitment to patients coming first.

Steven

Animal Research: One of FDA’s Core Values

Earlier this year, ABC's Nightline did a story about alleged abuses at the nation's largest primate research center. Fueled by this, the Great Ape Protection Act (HR 1326) now has 95 co-sponsors, compared to 29 sponsors on a similar bill in the last Congress.

The bill would virtually eliminate research using chimpanzees, even where there is no other animal model that could serve to predict safety in humans. This is a threat to animal research and, ultimately, to ourselves. The loss of chimpanzees would be a serious blow to research and would encourage animal rights activists to push for even more restrictions.

The value of animal research in the life sciences is considered an NIH issue. The research advocacy groups opposing the legislation are all part of the network that supports NIH

FDA Matters believes that the FDA and its stakeholders should be equally concerned.

Animal research is the vital first step in the development of new medical products. Before any safety or efficacy testing is permitted in humans, FDA must be satisfied with animal testing data submitted by the product sponsor. Pick any medical breakthrough and you will find animals were tested prior to humans.

For understandable reasons, we tend to focus on the human part of new products. What patients will be helped and by how much? By the time a company files a New Drug Application (NDA) or the equivalent in biologics and devices, the headline is the human data. While the animal data is always relevant, it has largely served its purpose as the gateway for human trials.

We talk about the people part without recognizing that the pipeline of innovative drugs and devices would narrow without chimpanzee research. It would collapse completely if a broader range of research on animals (e.g. monkeys, pigs, sheep, dogs, rats) was heavily restricted.

Everybody should be for protecting the welfare of animals. Any means to lessen our dependence on research animals should be welcome. Animals should always be treated ethically and pain reduced or eliminated. The fewest number of animals should be used to reach a conclusion that can be relied upon. Laboratories should be accredited and subject to inspection. Problems should be addressed within a facility under the watchful eye of government, accrediting and licensing agencies.

While purportedly about the welfare of animals, the House bill is really designed to grant rights to animals, starting with chimpanzees. There are elaborate arguments about whether animals should have rights or just have their welfare protected. For me, the choice is easy. I want a product or procedure tested in animals before it is given to me or my loved ones. I believe in protecting animals, but human rights come first.

Chimpanzees are crucial to animal research. If the House bill were to become law, important animal research might be halted in vaccines, hepatitis A, B and C, HIV/AIDS, malaria and some types of cancer. I am told that in these diseases areas, research on chimpanzees often provides essential information that cannot be obtained in any other way.

The importance of animal research needs to be a core value for FDA. The stakeholder community needs to "seize the day" and make clear where its stands. Those who benefit from animal research (including patients) need to provide the manpower and financial resources to counter the animal rights movement in America and its threat to medical progress for humans.

Steven

The ABC Nightline story is at: http://i.abcnews.com/Nightline/story?id=6997869&page=1.

A good review of appropriate animal research activities and processes is at: http://www.arvo.org/EWEB/dynamicpage.aspx?site=arvo2&webcode=AnimalsResearch

There are many good organizations that work to counter the People for the Ethical Treatment of Animals (PETA) and other animal rights organizations. One of the most effective is Americans for Medical Progress (AMP), an organization that educates media and the public about the importance of animal testing in advancing human health. Among other projects, they are organizing scientists to be more pro-active and articulate about the importance of testing on animals. AMP can always use more support for their work, www.amprogress.org.

The Beatings Will Continue…

….until the biopharmaceutical and medical device industries clean up their act.

It has been an expensive year for pharmaceutical companies. Billions of dollars have been paid to federal and state governments and whistleblowers in settlement of allegations and lawsuits. The complaints include off-label marketing and overcharging Medicaid, but there are many others.

While I am sure there are some "innocent" companies that are the targets of allegations, there are far too many expensive settlements and verdicts for industry to claim that they are victims of overzealous prosecutors and "get rich" whistleblowers. Earlier, FDA Matters called on the biopharmaceutical and medical device industries to recognize that "sales are not more important than laws." ("Off-Label Promotion and Whistleblowing" at www.fdamatters.com/?p=479)

I worry that companies figure they are ahead financially as long as profits exceed penalties. Not for long! The civil and criminal complaints are going to increase and settlements and verdicts are going to get larger. Legislation will get even more restrictive….and a wave of bad publicity will haunt the medical products industries and may forever destroy the public appreciation of the human benefits these companies provide.

US attorneys, state attorneys general, and inspectors general will keep probing until there is nothing left to investigate in the biopharmaceutical and medical device area. This won't happen anytime soon.

Over 180 pharmaceutical fraud cases involving more than 500 drug products are being investigated by the Department of Justice under the False Claims Act. Reportedly, most involve allegations of false and misleading statements made with intent to defraud or mislead. An additional back-log of 1000 whistleblower cases is waiting for DOJ to decide whether to participate. (From comments made by Jennifer Bragg, a partner in the law firm, Skadden, Arps, as reported in Dickenson's FDA Webview).

CEO's need to see corporate accountability as their personal responsibility. The handwriting is on the wall, based on the recent successful criminal prosecution of a small biotech CEO. Sometime soon, a US attorney is going to decide that monetary settlements should not be allowed to wipe out criminal charges. As a result, some senior executives in multi-billion dollar pharma companies may go to jail.

CEO's can no longer afford to trust themselves or their corporate management in judging whether they have followed the law. They need to verify. This requires tougher questions, independent audits of sales and marketing efforts, and alerting physicians to report to the company any meeting where a company representative made false or misleading claims. These companies should be hiring and empowering former prosecutors and investigators to review both policy and performance.

I believe in the transformative power of the biopharmaceutical and medical device industries to lengthen lives, deliver cures, control symptoms, and relieve pain. My advice to CEO's is clichéd but true. When the subpoenas arrive: "Do not ask for whom the bell tolls, it tolls for thee." Is anyone listening in the corporate suites?

Steven

The article cited in Dickenson's FDA Webview is available at:

'Whistleblower' Cases Dominate FD&C Act Prosecutions [639 Words] [ Price : $14.95]

With more than 180 pharmaceutical fraud cases now under investigation by the Department of Justice, FD&C Act prosecutions are now largely driven by "whistleblower" lawsuits, according to Eugene Thirolf, director of DoJ's Office of Consumer Litigation. 10/14/2009

Why Do Some People Dislike FDA?

Yesterday, I received separate posts from three organizations that are anti-industry, one of which dislikes FDA and one of which hates FDA. They are not alone in these feelings. There are many groups and individuals who believe that industry and physician professional societies run FDA. I don't accept their premise or the "facts" from which they launch attacks.

On the same day, I got an update from Americans for Medical Progress (AMP), an organization that educates media and the public about the importance of animal testing in advancing human health. FDA could not do its job without animal studies, both their own and those submitted by sponsors. AMP is among the "good guys" and can always use more support for their work, www.amprogress.org.

I would like to say that all the advocates, such as AMP, are realists and advance the common good by advocating for NIH and FDA….and that all the extreme critics and haters are irrational and inflammatory. It isn't that simple.

The FDA I know is a regulatory agency staffed by smart people trying to do their best. Given its mission, FDA is inherently imperfect and always vulnerable to criticism. The agency has been chronically understaffed and hasn't been able to give every decision the attention it might deserve.

I am on my tenth FDA commissioner. Bad decisions were made during each of their tenures and they all experienced bad days when nothing seemed to work the way it should. Meantime, hundreds of drugs and devices have been approved without subsequent mishap. Our food supply is vulnerable because of globalization, yet it is the safest in the world.

Those who dislike or hate FDA focus almost exclusively on those bad decisions and on the agency's most difficult days. In their minds, that is the FDA. They don't see the rest of the days where things went well: public health improved, patients received new FDA-approved therapies and more than 300 million Americans ate food without an outbreak of foodborne disease.

Because they ignore the good days and focus only on the bad, the haters feel justified in concluding that the agency is corrupt and deserving of vilification. I disagree vehemently with this premise.

I see some of the same problems they do, but recognize the problems are only a small part of FDA's mission and accomplishments. Given this wider perspective, it is misguided to impugn FDA and its staff. Bad days occur, but not because of impure motives or because agency officials blindly listened to the industry's views.

Those who dislike and even hate FDA serve a purpose. Scrutiny makes everyone think and work a little harder to make good decisions. Companies with safe manufacturing plants can still get in trouble with FDA if they haven't documented their safety-related activities. So, too, FDA needs to be able to show it has listened carefully and decided wisely. It can't just assert its decisions are good ones. Better documented and more predictable decisions are needed.

All of this can be taken too far….so that over-cautious decisions become a source of delay or failure in meeting the needs of patient and consumers. The haters would certainly like it that way. The extreme critics serve some useful purposes in a narrow sense, but they are wrong about the big picture of FDA's mission, intent and accomplishments. It is critical that we act civilly in the face of this hatred. That said, we must act to counter their arguments and make sure that the extreme version of FDA-bashing has no reputable standing in Congressional, media and public discourse.

Steven

More predictable decisionmaking at FDA was discussed in an earlier column.

In Praise of Predictability September 3rd, 2009

FDA has always found it challenging to make its actions predictable. This problem will worsen for a number of months while Dr. Hamburg redefines the agency's mission, policies, actions and working assumptions. Once this has been accomplished, the agency will become dramatically more predictable to stakeholders, including Congress. Read the rest of this entry »

“No Surprise” That Medical Devices Are Under Scrutiny

Five weeks ago, I wrote a column entitled, "Re-Evaluating the Medical Device Approval Process." It was not widely-read. I assumed it was because everyone already knew that a review was underway at FDA with more activity coming. Apparently, I was wrong.

A lot of people, including Wall Street, seemed surprised when FDA kicked its medical device re-evaluation effort into high gear over the last 10 days. I am not sure why they were surprised. The FDA re-evaluation was a certainty and has significant consequences for businesses and investors.

The medical device process and 510(k) approvals have been in question for a number of years. It has been a long time since there has been a thorough re-evaluation.  GAO is perpetually raising concerns about medical devices and a number of key Congressional leaders are interested. Also, the 510(k) approval process is necessary and defensible, but not easy to understand. It will continue to be a target for media, investigators, and crusaders until the process is re-evaluated and any needed changes made.

In April, Principle Deputy Commissioner Sharfstein acted affirmatively in response to the GAO's early 2009 report on medical devices. Last week, FDA set out its plans for a credible, effective re-evaluation of medical devices. This latest phase of the re-evaluation process featured three major items from FDA:

• Commissioning an IOM study of the medical device classification process, focused on the 510(k) process (which allows new devices to be approved by showing "substantial equivalence" to previously approved products);
  
• Release of FDA's analysis and recommendations based on review of the decision to grant 510(k) approval to a device manufactured by ReGen Biologics; and
  
• Creation of internal working groups to recommend and implement changes without waiting for the IOM report.
  

As FDA made clear during its press conference, the ReGen case is not the reason for FDA's review of the medical device approval process. Rather, approval of the ReGen device has proved to be instructive because so much went wrong. Among other things, there were violations of internal FDA protocols, inconsistent interpretations of the law, widespread confusion within FDA, poor communications with the sponsor company, and questionable involvement of Members of Congress

FDA has turned this experience into an inventory of ways to improve its performance in reviewing medical devices. FDA's analysis of the ReGen approval is well-done and worth reading.

My earlier column had two purposes: to alert readers that medical device re-evaluation is a large, pending activity within FDA; and to argue for FDA to take strong steps so that the re-evaluation process would not be driven by Congressional hearings and legislation.

FDA has now taken those strong steps. I hope that Congress will respect this effort and not intervene.

If the medical device approval process is under re-evaluation….then scientific and medical review staff at FDA (and their supervisors) are going to be careful in their actions. Protocols will be followed, every step will be fully documented, all interested staff will be involved, and near-final decisions will be reviewed more carefully.

This will slow the FDA approval of medical devices until needed changes have been made and confidence in the process restored. Does this actually surprise anyone?

Steven

My original column is at: http://www.fdamatters.com/?p=448. This includes my explanation of the issues and why re-evaluation of the medical device approval process was certain to occur. I conclude that the end-result will be "more than a few tweaks and less than an overhaul" of the medical device approval process.

The FDA press release announcing the IOM study of the 510(k) process: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183497.htm

The ReGen report and the FDA news conference transcript: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm183745.htm

Drug Reimportation: A Matter of Faith

Legislation to permit drug reimportation has resurfaced and the Senate may vote on it within the next 4 to 6 weeks. It may be considered as an amendment to the health reform legislation or come up as a free-standing bill. At stake is whether Americans can have access to drugs being sold in overseas markets at heavily discounted prices.

Advocates point to the unfairness of Americans paying more for the same drugs, which are often manufactured in the same overseas plants and use the same suppliers as pharmaceuticals being shipped into the US. If reimportation is permitted, they envision large savings for government programs, health plans and individual patients. They also believe that safety can be assured by limiting reimportation to countries with US-level regulatory and safety controls, such as Canada.

Opponents focus on the strict controls placed on drugs being manufactured for the American market and imported by US-regulated drug companies and wholesalers. While the world is awash in billions of dollars of counterfeit drugs, comparatively little enters the US under the current system. If counterfeits become more common, there is likely to be a significant increase in costly, sometimes deadly, therapeutic failures. This would jeopardize public health and wipe out much of the predicted savings.

Ideological positions have hardened on drug reimportation. There is far more shouting, far fewer efforts to reason and educate. How do we, as patients and consumers in a complex society, decide on the best path for Americans?

Years ago, a drug trade association ran a campaign with the seemingly-paradoxical theme: the only pill we don't test is the one you take yourself. The goal, as I recollect, was better public understanding of how testing and quality controls permeate every stage of drug development and manufacturing.

Because the actual pill can't be tested, the campaign made me realize that there is a critical leap of faith that the drug product you take is identical to the one that was originally shown to be safe and effective. This is not just a matter of chemical sameness, but also dissolution rates, absorption rates, purity, side effect profile, consistent safety and effectiveness across populations, etc.

I have the highest degree of confidence that a branded product is the same as the one that was originally tested and approved. I have nearly the same confidence in generics and regularly use them, although I have had at least one bad experience.

Beyond that, I become very concerned about drugs reimported from overseas. Among the potential problems: ingredient substitution, inconsistent manufacturing, lack of quality controls, inadequate inspections, lack of corporate accountability, and the absence of a strict chain of custody that prevents counterfeits.

This risk is compounded because consumers, pharmacists and doctors might never know whether a therapeutic failure was a result of an individual's biology or because of an inferior copy or counterfeiting. At least with brand and generic drugs, the pharmacy puts the drug's name and manufacturer on the label of the bottle and we can reasonably assume the accuracy of the information.

I have no faith that reimported drugs will, on a consistent basis, be identical to the original products in quality, safety and efficacy.

In most circumstances, potentially inferior goods sell at a steep discount to cover the consumer's risk of product failure. In health care, this is not considered acceptable. The promised price discounts from reimported drugs don't justify the risk to my health from a therapeutic failure.

Steven

It’s Time to Change CDER Funding

I did some crunching of FDA budget numbers for my column earlier this week on the Office of Regulatory Affairs (ORA). A by-product of my efforts was an analysis of how the Center for Drug Evaluation and Research (CDER) is funded.

As most readers know, bio-pharma companies pay user fees, based on activities (such as submitting a New Drug Application) and on the number of their manufacturing facilities. The amounts are set by law. As part of the arrangement, FDA agrees to certain performance goals, which are also specified in law.

We often hear how dependent CDER is on user fees. The actual numbers are startling and deserve to be well-aired.

In FY 09, CDER received $413 million dollars, of which $111 million goes to ORA for inspections and enforcement. The remaining $302 million is the appropriated amount available for CDER to fulfill its responsibilities. User fees add another $357 million.

Of CDER's $660 million, 45% comes from appropriations and 55% comes from user fees. The split is similar for employees. Nearly 1300 employees are paid from appropriated monies; 1500 employees are paid from user fee funds.

I do not believe that user fees are corrupting, as some have alleged. The oft-heard insinuation that user fees put FDA "in the pocket of industry" is nonsense.

Nonetheless, the appearance is terrible. Everyone in the FDA stakeholder community agrees—patient groups, companies, consumer groups and associations. No one favors more drug user fees…and most would like to roll back or eliminate them in favor of all-public funding. Is this possible?

The current drug user fee program (PDUFA IV) was signed into law on September 27, 2007 and covers five fiscal years. Although Congress won't act to renew the program before 2012, the FDA will be starting its public hearing process in the first quarter of 2010. This is the first step in creating FDA's legislative proposal for PDUFA V.

This seems like a perfect opportunity to build momentum for a rollback of user fees, leading to a much smaller PDUFA V. Except that it will never happen that way.

FDA won't recommend, and industry won't agree to, a smaller user fee program….unless they are assured that the same amount of funds will be replaced by appropriations. Additional appropriated funds above that level would be even better, since CDER has a lot of needs.

That brings the potential for a smaller user fee program back to Congress. It won't be simple. The user fee programs are authorized by the House Energy and Commerce Committee and the Senate HELP Committee. They will determine the size and scope of PDUFA V.

However, the House and Senate Appropriations committees control the amounts of user fees to be collected and made available to the FDA. If there is to be a larger, offsetting appropriation to replace some user fees, these committees will have the find the money.

A smaller PDUFA V could only happen if House E&C Chair Henry Waxman and House Appropriations subcommittee Chair Rosa DeLauro agree. Likewise, Senate HELP Chair Tom Harkin would have to reach agreement with Senate Appropriations subcommittee chair Herb Kohl to implement a smaller user fee program. The Senate may be easier, since Senator Harkin is the #2 Democrat on Senator Kohl's subcommittee.

One person can cut through all of this and lead the way to a smaller user fee program. When President Obama submits his FY 2011 budget to Congress next February, he could include additional appropriated funds to reduce CDER's reliance on user fees. A good start would be to get the proportion of user fees below 50% of CDER funding.

I wouldn't bet on this happening…..but I can dream, can't I?

Steven

The Uncrowned Prince of FDA

Which FDA line manager has the most appropriated resources to work with in FY 09? Is it Janet Woodcock, head of the drug center or Stephen Sundlof, head of the food center? The correct answer: neither.

The person with the most resources is Michael Chappell, Acting Associate Commissioner for Regulatory Affairs. In FY 09, he had primary responsibility for about $700 million, 1/3 of the agency's appropriation. He also had management responsibility for 3700 individuals, more than 40% of the agency's appropriated workforce. He is the uncrowned prince of FDA.

Few people know his name or much about the operational entity known as the Office of Regulatory Affairs (ORA). The Office's funding is tucked into each center's appropriation under the unremarkable line item: field. ORA does not even rate a link on the FDA home page. A description of ORA is two levels down:

The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy.  ORA supports the five FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States.  ORA also develops FDA-wide policy on compliance and enforcement and executes FDA's Import Strategy and Food Protection Plans.  http://www.fda.gov/AboutFDA/CentersOffices/ORA/default.htm

The relative invisibility of ORA appears to be intentional. For example, when the agency issues a press release about an enforcement action, the relevant center director gets the first quote; ORA is always quoted much further down.

Is ORA's continued low profile a good thing? I don't think so.

Congressional and media attention are increasingly focused on FDA's capacity to perform effective inspections and rigorously enforce the law. The agency's good name and public credibility are tied to success in these areas.

Since the Commissioner has so many roles, she needs someone to be the highly-visible, public face of tough enforcement at FDA. Two decades ago, when I worked at HHS, the Inspector General was a former professor who had become the supervisor of the organized crime units in the FBI's Chicago Office. He was a good, smart man and a friend…but you knew immediately that you didn't want to be a target of one of his investigations. FDA needs someone like him.

Well run, conscientious companies have little to fear. If you run a solid plant operation, import ingredients with care, use lots of system controls, and renew your commitment to pedigree and chain of custody, you are unlikely to be affected by a stronger ORA. If you have an inspections or enforcement problem: cooperate with FDA and correct it quickly.

On the other hand, if you are cutting corners, heedless to consumer and patient risk, or stonewalling the agency, you deserve what you get from ORA, strengthened and visible or not.

Commissioner Hamburg intends to make the agency more scientifically knowledgeable, more innovation-oriented and a more reliable partner in its interactions with industry and other stakeholders. A year from now, she will have little leeway to accomplish these goals if she hasn't taken the necessary steps to increase inspections and strengthen enforcement.

In doing so, it makes sense to take ORA out of the FDA shadows and make it a more visible force.

Steven

Post-script: While controlling a surprisingly large amount of the resources, ORA does not operate alone. Each center works with ORA to jointly develop work plans that direct inspection and enforcement priorities for the next fiscal year. My understanding is that this process is a serious endeavor that consumes an appropriately large amount of staff time and effort.

Off-Label Promotion and Whistleblowing

Whistleblowing and off-label promotion of drugs and devices have become hot topics because of the September 2 Pfizer settlement with the federal government. For those who were on vacation: Pfizer is paying $2.3 billion to settle criminal and civil complaints dealing with its marketing and sales practices on four drugs. They have also had to accept a stringent corporate integrity agreement with regard to pre-review and audit of its future marketing and sales activities.

While none of my views are specific to Pfizer, the company's settlement provides an opportunity to comment on off-label promotion….and to encourage bio-pharma and medical device companies to engage in deeper soul-searching.

Marketing departments should be able to do better. Even if the clinical trial data is ambiguous, FDA is usually precise in the indications it approves. That limits the scope of claims that can be made by a company. The FDA's promotion rules are far from perfect, but they are clear on most points. For virtually all medical products, it should not be hard for the sponsor to identify promotional claims and activities that are permitted.

Product marketing is a centralized function that requires employees to work together to develop programs and oversee initiatives. It is not an ad-hoc activity. I assume there are multiple sign-offs before any action is taken. Why are these safeguards failing? When things go wrong--which happens remarkably often--is it because everyone in the marketing department is drinking the same fatal Kool-Aid that sales are more important than laws and profits larger than penalties?

Sales practices are harder to control and will always leave companies vulnerable. I have often observed that there are three types of people: those who are shy, those who get over being shy, and salesmen. Medical products companies train sales staffs rigorously, re-train them often, and make them sign documents that attest to their knowledge of the marketing and sales restrictions on bio-pharmaceuticals and medical devices.

However, tens of thousands of sales reps have millions of interactions with prescribers. No matter how well trained and cautioned they are…there will be days when some reps cannot restrain their "inner salesman." How do you guard against that?

Whistleblowers serve a societal function that might not be served any other way. This is painful for me to admit, since I believe so strongly in working within an organization to make things right. I worry that "running to Uncle Sam" might be perceived as a better option than having a candid and concerned conversation with your boss.

However, in many situations, there may be no other way to document certain types of corporate wrong-doing. For that reason, whistleblowing and the resulting qui tam lawsuits are encouraged as a matter of public policy.

My conclusion: it is difficult for bio-pharma and medical device companies to conduct business in a way that makes whistleblowing unnecessary. Nonetheless, FDA-regulated industry can do better than they are presently. We should expect medical product companies to serve patients, prescribers, and shareholders without breaking the law. For those who think the promotion rules are illogical or counterproductive, the remedy is to work for policy changes, not to ignore FDA rules.

I believe that leaders and staff of medical products companies are well-meaning and committed to improving the health of patients. It is detrimental to see off-label promotional activities that can be interpreted as blatant bad faith.

Am I missing factors that might lead to a different conclusion? I encourage readers to post constructive comments to set me straight.

Steven

Notes on the news:

• My September 6^th comments on President Obama's options leading into tonight's speech to Congress on health care reform and how that might affect FDA: http://www.fdamatters.com/?p=471
  
• Senator Dodd has decided not to take the HELP chairmanship. Here are my August 30^th comments on the other contenders and the trade-offs involved: http://www.fdamatters.com/?p=459