Americans rely on the pharmaceutical industry to develop and produce life-saving and life-enhancing drugs. Americans also rely on the Food and Drug Administration to determine drug safety, monitor emerging risks, and inform doctors and their patients in a timely way when problems come up.
This year, new concerns about the diabetes drug Avandia spurred worries of another Vioxx situation and provided further evidence of a badly broken post-market monitoring process within the FDA, one that’s supposed to protect Americans once a drug is on the market.
I’ve taken a close look at the federal government’s drug-safety agency over the past three years as part of my responsibility to make sure that tax dollars spent for drugs through the Medicare and Medicaid programs are being used for drugs that work and are safe. Drugs naturally carry risks, but the health benefits ought to outweigh the risks.
My oversight work has uncovered an FDA that is too cozy with the drug industry it regulates.This relationship fosters a culture that inhibits the scientific process. Instead of being allowed to contribute to a judicious outcome, scientific dissent from FDA scientists is suppressed and FDA scientists suffer reprisals for raising concerns about drug risks.
In fact, starting with the FDA’s Dr. Andrew Mosholder, who sounded the alarm in 2004 about suicide risks for kids taking anti-depressants, and repeating with Dr. David Graham, Dr. David Ross and Dr. Rosemary Johann-Liang, we’ve seen the concerns and warnings of highly regarded and committed FDA scientists brushed aside by FDA higher-ups, despite the high stakes for public safety.
Reform is needed because the FDA’s credibility and responsibility rests on its commitment to the scientific process and to public safety.
Despite a lot of talk, it seems pretty clear that the FDA won’t make necessary changes on its own, especially when it comes to considering and disclosing new health risk information about drugs already on the market.
Reformers looked to Congress this year and were left disappointed by the broad-based Senate FDA bill passed in May that failed to specifically strengthen post-market review by the agency. This week, the House Energy and Commerce subcommittee on health will consider its version of FDA legislation. It’s up to these House leaders to recognize what’s at stake for public safety and to adopt a better bill than the one passed by the Senate.
The House of Representatives has the opportunity to take the FDA office that monitors and assesses drugs on the market out from under the thumb of the FDA office that approves drugs in the first place. An amendment I introduced would have done this, but Senators rejected it by just one vote.
The amendment was based on the bipartisan proposal I’ve twice introduced with Sen. Chris Dodd (D-Conn.), although it does not go as far. Our comprehensive legislation would elevate the post-market review office within the FDA and make it completely separate from the new drug approval office in the FDA while still requiring the two offices to work together. The amendment would leave the post-market review office where it currently sits on the FDA organizational chart but provide for joint decision-making with the drug approval office. Our goal is to give the post-market review office real clout, rather than the consultant status it carries today.
Beyond the FDA bill now making its way through the legislative process, Congress can take steps to improve the study of medical treatments, including the effectiveness and safety of drugs on the market. In May, I reintroduced with Sen. Max Baucus (D-Mont.) a separate proposal to give researchers at federal agencies and university-based and other research organizations highly controlled access to data on hospital, physician and prescription drug benefits that are provided to Medicare beneficiaries.
There’s tremendous potential for improving the public safety by making this rich source of information available to experienced and credentialed researchers. Drug trials often include only a few hundred subjects. These trials are no match for the wealth of information that’s available after a drug is on the market and millions of people start taking it. The Medicare data initiative would tap that valuable information and dramatically benefit public safety and public health. It would do so in a way that makes sure the strongest safeguards are in place to protect privacy and confidentiality.
The FDA reform effort must succeed. The evidence that’s piled up during the past three years and the experts who have weighed in — including the prestigious Institute of Medicine — all say the nation’s surveillance of the safety of pharmaceuticals on the market needs to be improved. Courageous FDA scientists have vowed to be instruments of change, and I’ll be working as well for changes to enhance public safety and make the work of the FDA more transparent and, therefore, more accountable to the people who rely on it, the American public.
Sen. Chuck Grassley (R-Iowa) is the ranking member on the Finance Committee.