Friday, May 16, 2008

More on FDA and Pre-Emption

I've written a couple of times on the issue of pre-emption, which states that manufacturers cannot be held liable for any drug or medical device approved by the FDA. This includes drugs such as Vioxx, the approval of which was in no small part contingent upon ghost-written, dishonest research publications promoting the drug, despite evidence that it may have been harmful. In another instance, Johnson & Johnson, makers of the Ortho-Evra birth control patch, withheld evidence that it released significantly more estrogen than advertised and presented a danger to patients.

If the Supreme Court were to rule in favor of pre-emption in a case it has before it, Americans who suffered as a result of manufacturers' malfeasance and dishonest practices would have no outlet, and would assume the liability themselves. The House Committee on Oversight and Government Reform held a hearing this past Wednesday on the subject, hearing testimony from Dennis Quaid, various doctors, and lawyers, with all but one opposing pre-emption. [Obviously, Henry Waxman controlled the invitations, so the discrepancy is anecdotal at best.]

William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston

Dr. Maisel testified about medical devices, and the specific case of Mark Gleeson, victim of a short-circuiting pacemaker. As Dr. Maisel stated, "the U.S. Food and Drug Administration regulates more than 100,000 different medical devices manufactured by more than 15,000 companies, [and] receive several thousand new and supplemental device applications annually."

That the FDA would be able to catch every flaw or questionable scientific backing in all of those devises, in addition to regulating the 11,000 drugs on the market is ludicrous.

St. Jude Medical, the manufacturer of Mr. Gleeson’s pacemaker, had become aware of the short circuit problem 2 years prior to Mark Gleeson’s pacemaker failure because other faulty pacemakers had been returned to the manufacturer. After studying the problem for over a year and validating a fix, St. Jude asked for and received FDA approval for a modified version of the device that corrected the problem. This approval came several months prior to Mr. Gleeson’s device failure although the reason for the device modification and a patient warning were not publicly provided at that time. Furthermore, St. Jude Medical continued to distribute the already manufactured potentially faulty pacemakers. Mark Gleeson was unlucky enough to receive one as his replacement device – even though corrected pacemakers had been built and were available. Eight months after receiving FDA approval for the corrected device and nearly 2.5 years after initially learning of the problem, St. Jude Medical issued a recall of 163,000 pacemakers, including Mark Gleeson’s new unit.

The timeline in this particular case should eradicate any misconceptions about the efficiency of the FDA and its ability to protect consumers. St. Jude was aware of the problem a full year ahead of providing him the first pacemaker, and had a fix several months prior. Once it did provide a fix, neither the fix nor the underlying issue were made public. Indeed, when Gleeson's first pacemaker failed, he was provided with another faulty device, despite the availability of the newer model.

All of the issues involving the short-circuiting pacemakers became publicly available only 2.5 years after the problem was discovered.

Aaron S. Kesselheim, M.D., J.D., Harvard Medical School, Division of Pharmacoepidemiology

These lawsuits are important because in the current US regulatory system, a drug’s manufacturer plays the central role in the development and dissemination of knowledge about its product, and therefore exerts considerable influence over what is known about its product and how it is used in the marketplace.

This fact, of course, places greater emphasis upon the issues surrounding Vioxx (ghost writing) and Ortho-Evra (suppression of detrimental evidence). If the manufacturers themselves are in control of what the FDA (and the public) knows about the drug, pre-emption would place them in total control both coming and going. Not only are they capable of controlling what is known, but once that drug is approved on that cherry-picked information, the public is helpless but to hope nothing bad happens.

Dr. Kesselheim also brings up the limited testing that drugs go to prior to release, "often on patients healthier than those for whom it will be prescribed." Given that the FDA doesn't have the resources to follow every drug for its lifetime on the market, it is often up to the manufacturer to track adverse events and other safety issues.

Manufacturers have a strong financial incentive to promote their drugs’ effectiveness and increase sales of their products, but manufacturers may also sometimes be faced with their own safety-related data that suggest limiting use of their product, or withdrawing it from the market altogether.

Vioxx is again held up as an example, along with Baycol. In the case of Baycol, the manufacturer intentionally failed to follow-up once the drug went to market: "A company memorandum reportedly stated 'If the FDA asks for bad news, we have to give, but if we don’t have it, we can’t give it to them.'"

Then there's the lovable sales reps:

At the same time, a drug’s manufacturer manages how the drug is promoted to physicians and patients. Numerous studies show that these promotional messages are extremely powerful in influencing physicians’ prescribing practices. However, like any sales messages, they also tend to inflate the benefits of a medication and downplay its risks. Vioxx’s manufacturer continued actively promoting its wide use even after it reportedly knew about the drug’s association with cardiovascular adverse events. Such promotional tactics included specific instructions to its retailers how to dodge questions from physicians concerned about these side effects.

David Vladeck, J.D., Professor of Law, Georgetown University Law Center

Let’s be clear about this: Under FDA’s view, consumers are forced to assume the risks of unsafe drugs and medical devices. At the same time, manufacturers of drugs and medical devices who fail to take reasonable steps to assure their drug or device is safe are immunized from liability, and, these days, essentially immune from FDA enforcement.

Thus, instead of having liability claims as a second front of protection for the consumer, an over-burdened FDA beholden to the forthrightness of the manufacturers becomes the only form of coverage. Given the track record, it is fact, not opinion, that this is an ineffective system and to the severe detriment of consumers.

But here's the real kicker. Republicans love to rail against 'activist judges' and unelected officials ruling by fiat. But only on select issues, namely those they don't agree with. Tort reform (read: elimination) is a different story:

What makes this result all the more indefensible is that the decision to wipe away state liability law was not made by Congress through legitimate, democratic means. Instead, it was made by unelected and unaccountable agency officials — many of whom worked for drug and device companies before their government service and have returned or will return via the revolving door to represent the same companies. These decisions were not made in a transparent, publicly accountable way. Rather, they were made in obscure regulatory documents, with no opportunity for public input, and with no regard for the clear-cut requirements of Executive Order 13,132, which disfavors preemption and requires agencies to consult with states, local governments and the public before making preemption decisions.

I'm sure George Bush and John McCain will come out against 'judicial activism' if the Supreme Court legislates from the bench on this issue.

The federal government has regulated the sale of drugs for one hundred years without any hint that state liability actions interfered with FDA’s ability to do its job. Nothing in the statutes FDA administers suggests that they oust state liability actions for drug products. Indeed, FDA has long taken the view that state liability litigation for pharmaceuticals is an important, independent discipline on the market. And Congress has not acted to preempt or limit state liability actions, even though Congress has long been aware of the steady procession of liability actions against drug makers — including those that pre-date FDA and its forerunners.

The issue of pre-emption isn't even close. Tactically speaking, the insinuation that the FDA is effective as the exclusive check on pharmaceutical and medical device safety is fallacious and ludicrous, given the extensive pile of evidence to the contrary.

But aside from the logistics, there remains the legal issue. If the Court were to decide in favor of pre-emption, it would do so in contradiction to a century of precedent, both within Congress and the FDA, itself.

Pre-emption would be a great coup for those in the Bush administration who will be returning to corporate jobs in 2009, many in the pharmaceutical arena. It would also take a sledgehammer to consumer protection and legitimate governance.

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