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When there are large numbers of claims associated with a single product, they may be part of a mass tort. It basically means that an act of negligence on the part of an individual or company resulted in injuring many people. Many factors are considered when deciding if a claim should be part of a mass tort.
A few months ago, Professor Marcia Angell picked up her pen to describe the institutional failings of the FDA’s drug approval regime, and to make some suggestions for reform. Academic achievements aside, Angell is known for being a thorn in the pharmaceutical industry’s side, a tireless advocate for drug safety and efficacy. At big pharma’s profit party, Angell is, basically, a major buzzkill.
There is, Angell writes,
growing evidence that the Center for Drug Evaluation and Research (CDER, pronounced “cedar”), the part of the agency that regulates prescription drugs, has become the servant of the industry it regulates. This has resulted in the sale of drugs of uncertain benefits, some with serious side effects, and in the agency’s failure to respond promptly to evidence that a drug is dangerous. There is no better example than the agency’s decision to allow the diabetes drug Avandia to remain on the market after having determined three years ago that it increases the risk of heart problems and despite the existence of a similar drug that appeared safer.
Angell lays out the problem:
Industry influence on the FDA is exerted in two major ways—first, through congressional legislation largely dictated by industry lobbyists, and second, through administrations that are beholden to industry, and sometimes, as in the case of the George W. Bush administration, openly hostile to the very idea of regulation. The result is a climate in which CDER employees are inhibited from acting against drug company interests even when the agency has legal authority to do so. In addition, drug companies spend millions of dollars to directly lobby the FDA, even though it seems improper to permit a lobbyist to walk in the door of a regulatory agency.
The Obama administration is friendlier to regulation than was the Bush administration. The new FDA leadership has taken steps to make the agency’s actions more transparent, and has set up a program for doctors to report misleading drug ads. But to my knowledge, there has been little substantive change in CDER’s organization or procedures, and it retains the same director.
So what are Angell’s ideas for reform?
1. Repeal the Prescription Drug User Fee Act (PDUFA). The Act inadvertently created economic incentives for the cash-strapped CDER to err on the side of approving drugs, rather than rejecting them or ordering further tests. This may be a good thing for pharmaceutical industry profits, but it doesn’t exactly promote safety or an independent, neutral regulatory body. As Angell notes, “Fees paid by private companies now account for more than half of CDER’s budget.” The act further distorted the work of CDER by pushing the center to its overstaff drug approval process at the expense of adequate staffing for the center’s other, “equally important functions—such as ensuring drug safety, approving generic drugs, reviewing advertising for accuracy and balance, and inspecting manufacturing plants.” Angell argues that we should expand funding for the center’s other functions, and that we should fund the center entirely with public money.
2. Next, Angell makes the case for strengthening the power of the CDER’s Office of Surveillance and Epidemiology (OSE) over the center’s Office of New Drugs (OND). In the current bureaucratic structure, the OND is for the most part only accountable to itself, a classic recipe for disaster in public and private sectors alike. Angell thus proposes giving the OSE regulatory power over drugs once they have been approved by the OND, thus providing some oversight of the OND’s decisions.
3. Angell’s third recommendation highlights a problem of regulatory capture within the FDA that crosses a number of legal and ethical lines:
Third, members of CDER’s standing advisory committees should have no financial ties to drug companies (except for research support provided under carefully restricted conditions)…in 75 percent of committee meetings at least one voting member did so. Although advisers are not supposed to vote on matters involving companies with which they are financially associated, waivers are granted so frequently as to be almost routine.
Conflicts of interest matter. Consider the case of Vioxx, the arthritis drug that was removed from the market in 2004 because it was associated with an increased risk of heart attacks and strokes. In 2005, a special FDA panel, consisting of two of the standing advisory committees, held public hearings to consider whether Vioxx and two other drugs in the same class, Bextra and Celebrex, were safe enough to stay on the market. After three days, the panel recommended that all three drugs be allowed on the market, perhaps with strong warnings on the labels and a moratorium on advertising directly to consumers.
About a week later, however, The New York Times revealed that ten of the thirty-two members of the panel had financial ties to the makers of the drugs. If their votes had been discounted, the panel would have recommended that only Celebrex stay on the market. In a departure from its usual practice, CDER, no doubt embarrassed, rejected the advice of the full panel and allowed only Celebrex to stay on the market. If not for the revelations in The New York Times, the decision would probably have gone the other way.
4. Drug companies that are supposed to carry out additional safety tests once they have already begun marketing a drug must be held to the commitment. As Angell writes, companies routinely flout these requirements. “CDER has never pulled a drug off the market because of a company’s recalcitrance in conducting a post-marketing study. It should. If drug companies know the FDA will never use its authority in this way, they have no incentive to meet their commitments.” Indeed. The CDER would do well to adopt a bit of the stick in these cases before products injure consumers and lead to lengthy litigation over tort liability. As we’ve said before, if drug companies really want to avoid lawsuits, they should support a stronger FDA that could help keep them honest and prevent dangerous products from going out on the market.
5. Angell proposes limiting drug approvals to three years for new products, during which time direct advertising is prohibited. Subsequent approval would then require a “favorable balance” of a risk-benefit analysis conducted on the drugs during this period.
6. “Sixth, the FDA should review generic drugs as rapidly as brand-name drugs, and be adequately staffed to do so.” This proposal is interesting, and stands out from the rest because it’s less concerned with product safety and more with the question of the FDA favoring name-brand companies over generic product companies. This isn’t our area of expertise, but Angell argues that there are no non-arbitrary reasons behind this disparity and so amounts to simply ‘protecting’ the profits of some companies over others.
Saving a discussion of Angell’s seventh and eighth proposals for another time, it is her last idea that speaks directly to the crux of the problem, scientifically and as a matter of public policy. Angell suggests that, “as a condition for enrolling human subjects, all clinical trials, without exception, should be registered at inception in a public database and the results shown when the research is completed.” As we’ve written before, when drug companies conduct trials overseas, they are under no practical obligation to tell the public (or the FDA) about clinical trials that don’t go so well – those showing a lack of medical benefits, and those raising safety concerns. Put simply, you’re not using the scientific method if you throw out the tests that don’t go your way. In order to conduct clinical trials that mean anything, it’s essential to stack up the record of all trials conducted against each other. Cherry-picking test results isn’t science, and it’s a deadly serious problem.
All of the proposals discussed here at least merit serious consideration. But in practical terms, this last proposal might be the most important. There’s always a danger with bureaucratic reforms that the most aggressive companies simply figure out new ways to subvert the system and skirt regulation. The beauty of projects that make data public and open to scrutiny is that it can push people into behaving better without having to create bigger bureaucracies to police industry. ProPublica’s Dollars for Docs, for example, allows a growing number of people around the country to look up their doctor to see if he or she is on the take from pharmaceutical companies. Regulating those payments is a good idea, but empowering consumers to protect themselves is a lot cheaper. Many of the most dangerous drugs produced and sold in the last decade went onto the market with the companies knowing about and hiding worrisome test results. We should of course strive to reform the FDA – and there’s no one better than Angell to figure out how to do so – but this last proposal alone might give us the momentum to work collectively towards a safer pharmaceutical industry. Widespread access to and use of this information could create pressure on the FDA to do a better job of enforcing its duties and could help journalists, consumers, and doctors educate themselves on drug safety issues.
-Benedict Morelli and David Ratner
