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Skullduggery Over FDA

tagline 1997

Republicans and Pharmaceutical Industry Target the FDA in a Dangerous Plan to Undermine the FDA


‘Two lone voices’

Gregg Gonsalves, TAG's Policy Director and Washington watchdog, has just returned from a week in our nation's capitol, on the heels of a major defeat in the Senate on an FDA reform bill known as S. 830. In the pages that follow, Gregg explains why the proposed reforms are cynically crafted and pernicious, and how they end up putting the foxes in the questionable role of protecting the henhouse. "Instead of modernizing the FDA," he writes, "the bill really takes us back to a past where unsafe and ineffective drugs regularly threatened the public health."

As Congress reconvenes for its autumn semester this year, one of the first bills likely to be considered on the Senate floor is the Food and Drug Administration (FDA) Modernization and Accountability Act [S. 830]. Groups representing the pharmaceutical and medical device industries are championing this legislation claiming it will "bring safe and effective new medicines to people sooner." Appropriating the language of AIDS activism, industry is urging its supporters to tell Congress to approve the bill and "to cut the red tape that is delaying cures." However, the FDA Modernization and Accountability Act has little support from groups representing patients, consumers and health care professionals. AIDS organizations are roundly opposed to the bill because it erodes the FDA's ability to evaluate the safety and efficacy of new drugs and allows industry to make claims about drugs without substantial evidence to support their claims.

Senator James Jeffords (R-VT), an erstwhile GOP moderate, crafted the bill behind closed doors with industry representatives. There have been no public hearings on the bill although it will effect the health and well-being of millions of Americans. The bill also endangers the reauthorization of another piece of legislation that everyone, patients and industry alike, agrees has speeded up the drug approval process: the Prescription Drug User Fee Act (PDUFA). PDUFA has cut drug approval times in half at the FDA by allowing the agency to use industry contributions or users' fees to hire additional reviewers. The act expires this fall and needs to be renewed in order to allow the FDA to retain staff hired under the legislation's authority. What are some of the provisions of the FDA Modernization and Accountability Act that make it so hazardous to the health of people with HIV infection and other serious and life threatening conditions?

Weakening the Efficacy Standard

One of the major goals of the proposed legislation is to reduce the number of clinical trials needed for the approval of new drugs from two to one. Industry is pushing for this provision because it would require them to do less clinical research before receiving approval to market new agents. This would reduce their own research and development costs while allowing them to get their products on pharmacy shelves faster than ever before. However, the FDA already has regulatory authority to approve drugs in special circumstances based on the results of one clinical study with confirmatory evidence. Moreover, the FDA has already shown great flexibility in approving drugs, especially for AIDS. We can now count the time it takes to approve AIDS drugs in days and weeks, rather than months and years. After years of effort by AIDS activists and others, the agency has finally found a way to maintain the delicate balance between expeditious review of new drugs and a rigorous evaluation of their safety and efficacy. In a shameless capitulation to industry greed, The FDA Modernization and Accountability Act recklessly tips the balance away from careful oversight. By completely removing the ability of the FDA to require two clinical trials for marketing, patients will know less and less about the safety and efficacy of drugs they are putting in their bodies. Instead of modernizing the FDA, the bill really takes us back to a past where unsafe and ineffective drugs regularly threatened the public health. Instead of holding industry accountable for the safety and efficacy of its products, the bill promotes corporate irresponsibility by weakening the requirements companies must fulfill to sell their goods.

The Fox Guarding the Henhouse

Not content with gutting the efficacy standard, the bill's sponsors have included provisions that allow medical device companies to directly contract with private reviewing firms to recommend approval of their products. This means a maker of a new pacemaker or any "implantable, life-sustaining or supporting device," could handpick, hire and pay a for-profit company to review its new device application and recommend approval to the FDA. This is a ludicrous invitation to conflict of interest. Device manufacturers would seek out review companies with the most relaxed appraisal standards and for-profit review companies looking for their business would have no incentive to provide an exacting evaluation of new products. Consumer groups like the Patients' Coalition (of which TAG is a member) have suggested a more reasonable alternative. The Patients' Coalition recommend the institution of medical device users' fees modeled on the drug users' fees collected by the FDA under PDUFA. This would allow the agency to hire additional reviewers to expedite the approval of new devices without compromising the health of the American public.

Unfettered Promotion of Off-Label Drug Use

One of the most difficult provisions of the bill for AIDS treatment advocates is a proposed amendment that would allow off-label promotion for unapproved uses of prescription drugs. Off-label drug use for treating HIV is common. In a study by Carol L. Brosgart of the Community Consortium in San Francisco, Brosgart and her coworkers found that in a cohort of over 1,100 patients, 81 percent received at least one drug off-label and that 40 percent of all reported drug use was off-label. The bulk of the off-label drug use was for the treatment and prevention of HIV-related opportunistic infections. Despite widespread off-label drug use in HIV infection, AIDS groups are opposed to the amendment that would allow companies to promote drugs for uses that are not approved by the FDA.

While supporting the right of doctors and patients to use drugs off-label, AIDS groups do not support the right of drug companies to market their drugs for these unofficial indications. The Patients' Coalition and others have argued that off-label promotion provides "a disincentive for drug companies to conduct research into new efficacious and safe uses of approved products." In HIV infection, the optimal use of many drug regimens is still to be determined. For instance, we do not know when to start combination antiretroviral therapy or which combination is best to begin with. We also do not have a full picture of the complex interactions of the protease inhibitors with many other common medications. Many of the unanswered questions about these drugs are about their use in off-label indications. AIDS advocates argue that the right to market and promote drugs for expanded indications must be linked to the completion of studies that confirm the clinical benefit of these broader uses. Otherwise, people with HIV infection will be forced to make important treatment decisions without adequate information to guide their judgments.

Accelerated Approval: Republican Style

Several years ago, in the quest to expedite the approval for drugs for patients with serious or life-threatening conditions, the FDA enacted regulations that allowed for the approval of drugs based on surrogate endpoints. However, this accelerated form of approval is contingent on the completion of post-marketing studies confirming the clinical benefit of the surrogate effect.

The FDA Modernization and Accountability Act would codify the accelerated approval process but without requiring post-marketing studies. This provision would essentially allow approval of drugs for serious and life-threatening conditions without evidence of their ability to extend the health and life of patients. The accelerated approval regulations reasonably balanced the need for quicker approval for drugs for AIDS and other serious illnesses with the need for information on the clinical effects of these agents. However, Senator Jeffords' bill would endanger the lives of people with HIV infection by depriving them of the most basic knowledge about the drugs that they are taking.

AIDS advocates are urging that provisions be included in the legislation that actually enhance the ability of the FDA to require post-marketing studies of new drugs to elucidate their clinical effects. The Patients' Coalition has proposed that the Secretary of Health and Human Services be allowed to impose civil fines on companies that do not conduct post-approval research. This would strengthen the accelerated approval regulations instead of watering them down.

Epilogue

The FDA Modernization and Accountability Act would radically transform the regulation of drugs, medical devices, food and cosmetics in the United States. Currently, the FDA enjoys wide support among the American public for its role in protecting patients from unsafe and ineffective drugs. The American public is clearly not clamoring for the kinds of drastic changes in the agency that the FDA Modernization and Accountability Act would provide.

Why then has Senator Jeffords decided to champion the narrow, commercial interests of the pharmaceutical and medical device industries over the wider interest of protecting the public health of all Americans? Clearly, the Senator has been led down this path by the powerful pharmaceutical industry lobby. But he is not alone. Important Democratic senators like Christopher Dodd of Connecticut and Barbara Mikulski of Maryland are co-sponsoring the bill as well. On this bit of legislation, there seems to be a bipartisan willingness to feed at the trough of the drug and medical device companies. Meanwhile, the Clinton Administration refuses to oppose all but the most noxious provisions of the act. As TAGline went to press, the Senate overwhelmingly approved the FDA Modernization and Accountability Act, 98 to 2. The two lone voices of opposition to the bill were Democratic Senators Edward Kennedy of Massachusetts and Jack Reed of Rhode Island. The bill is now rapidly moving through the House and will in all likelihood be signed into law by the President.