Prescriptions for Drug Safety

Reforming U.S. Prescription Drug Regulations to Protect Consumers

New report offers five policy prescriptions for improved drug safety that Congress should consider to protect consumers.

Read the full report (pdf)

Protecting American consumers from the potentially fatal side effects of prescription drugs already behind pharmacy counters should be one of the top tasks of the U.S. Food and Drug Administration. Yet the FDA today has little authority and even less money to police prescription drugs after it has given final approval for a new drug to be prescribed by doctors across the country. Under current rules and regulations approved by Congress most recently five years ago, the presumption was that the FDA’s rigorous testing of prescription drugs prior to approval for sale to the public offered enough protection to consumers. That presumption is wrong.

The Prescription Drug Use Fee Act of 1992, or PDUFA, which Congress renewed in 1997 and 2002 and which is up for renewal again this summer, authorized the FDA to establish a clear but streamlined new drug approval process alongside the means to pay for the necessary extra staff—user fees from the pharmaceutical industry. PDUFA worked wonders for its users: double-digit profit margins because Big Pharma can now get more new drugs approved more quickly. The average time it takes the FDA to ap- prove a new drug has dropped by 40 percent since PDUFA was first implemented; 50 percent of the world’s new drugs are now launched first in the United States, up from 8 percent in 1992.

The problem, as recent research has shown, is that FDA staff at its Center for Drug Evaluation and Research is trying too hard to meet the deadlines of PDUFA. The prestigious Institute of Medicine pointedly notes that the funding method and swift review guidelines of PDUFA are “excessively oriented toward supporting speed of approval and insufficiently attentive to safety.” Indeed, a study published earlier this year by George Washington University’s School of Public Health and Health Services found that the rate at which drugs already on the market registered unforeseen health safety problems was appreciably higher for those drugs approved by the FDA within PDUFA’s expedited approval timelines.

Yet the headline news about the adverse effects of some of these drugs, such as the heightened risk of heart attacks from the painkiller Vioxx and of liver failures from the antibiotic Ketek, compete with the results of another reform implemented by the FDA since the introduction of PDUFA—direct-to-consumer advertising by the pharmaceutical industry. Even as drug industry executives face serious charges of not doing enough to ensure the safety of their own drugs once they are approved for sale by the FDA, these companies’ marketing mavens are spending billions of dollars advertising their products to consumers directly through the media.

The high cost of those drugs to American consumers relates directly to the cost of the pharmaceutical industry’s media marketing programs and user fees paid to the FDA to get drugs approved quickly. The price of prescription drugs increased 8.3 percent annually between 1994 and 2004, the last year for which complete data are available, compared to the average annual rate of total inflation of 2.5 percent. Spending on prescription drugs grew by 59 percent between 2000 and 2005, while all other health expenditures grew by 40 percent.

The upshot: higher profits for the drug industry but less safe drugs for consumers due to the unforeseen consequences of PDUFA and direct-to-consumer advertising. But what’s worse is that there is still no regulatory system in place to review the safety of prescription drugs after the public is allowed to purchase them.

Congress has an obligation to fix what ails the FDA’s drug review process as it works to reauthorize PDUFA in the coming months. And there are plenty of good ideas on how to do so: new proposals from the Institute of Medicine; a set of policy recommendations published recently by scholars in the Archives of Internal Medicine; and key bipartisan legislation already proposed in the Senate and House of Representatives.

Yet both chambers of Congress have recently passed bills that fall short of the mark.

That’s why the Center for American Progress today offers five policy prescriptions for improved drug safety with the intention of influencing the final bill as key members of the House and Senate now in conference committee try to work out differences in legislation passed by the two chambers. Specifically, CAP proposes that Congress:

  • Eliminate the almost automatic thirty-month patent exclusivity extension allowed under current law so that generic drugmakers can compete that much more quickly with pharmaceutical companies that have already enjoyed the full extent of patent protection.
  • Restore the moratorium on direct-to-consumer advertising in effect prior to 1985 so that direct-to-consumer advertising follows the same guidelines as advertisements directed at health care professionals, including full disclosure of side effects and warnings. 
  • Create an independent Center for Post-Market Drug Evaluation and Research outside of the FDA to establish an effective system for post-marketing surveillance of drugs. 
  • Require pharmaceutical companies to undertake post-marketing phase IV safety studies and make the results available, along with Phase III safety trials, on a government website. 
  • Discourage the proliferation of “me too” drugs by requiring that new drugs go through extensive comparative clinical trials and are tested for safety and efficacy. Fully fund the FDA and the new Center for Post-Market Drug Evaluation and Research so that the agency and the new Center can do their jobs properly.

These five steps are easily proposed but not so easily implemented. The complexity involved in all five reforms means that Congress must pay special attention to how the safety of our drugs came to be compromised by previous legislation and subsequent regulatory action.

This paper will detail the legislative and regulatory history of drug safety efforts in the United States over the past 100 years, with particular attention paid to the past 20 years in which successive victories by the pharmaceutical industry came at the expense of consumers. Once we have underscored exactly how drug safety came to be compromised at the FDA, a more complete analysis of our prescription drug policy proposals points the way, we believe, for Congress to act.

Read the full report:


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