Senate committee sends strong drug safety bill to the floor

Your emails and phone calls paid off. Click here to call your Senator! The drug safety bill (S. 1082) going to the Senate floor includes these improvements, also described in the New York Times here:

  • Makes more research public. Requires results of Phase III and IV clinical trials to be made public in a readily available clinical trials registry so doctors and patients can see what researchers learned before the drug came on the market.
  • Increases funding for safety reviews of drugs already on the market. The bill would direct the FDA to track the side effects of popular drugs by reviewing existing data like health records collected by insurers. The agency is now able only to track drug side effects through doctors and patients’ voluntary reports, a system incapable of uncovering problems like those with Vioxx.
  • Gives the FDA the power to fine drug makers that fail to carry out promised safety studies. Presently, the agency has no power to enforce these pledges, so only a fraction are completed.
  • Clarifies authority to force drug label changes for safety. The new provision clearly states when and how labels will be changed, and limits the dispute resolution process to four months. Currently, the FDA has to negotiate a label change with the company, and in the case of Vioxx, it took 14 months to get safety warnings on the label.
  • Opens the drug approval process. The public will now be able to see the concerns of FDA scientists who may have safety issues with a drug being approved for market. Currently, dissenting FDA opinions about safety are kept from the public. This new provision will allow researchers outside the FDA see if reviewers had any doubts about the safety of a drug.

But several amendments that would weaken the bill are expected to be offered on the Senate floor. Those include requiring years of 'study' before the FDA could act on a serious safety issue, and limiting the FDA's ability to curb massive advertising campaigns for new drugs with potential safety issues. Discuss the bill and the drug company lobby effort to weaken it here.

Frequently Asked Questions about
S. 1082, the Food and Drug Revitalization Act

S. 1082: What does the bill do?

S. 1082 gives the FDA more funding and flexible tools to ensure the safety of prescription drugs.

The drug safety provisions will:

  • improve the surveillance of post-market adverse events those side effects that show up once a drug is used by millions of patients over time;
  • allow the FDA to more quickly communicate possible risks to doctors and patients; and
  • give doctors and patients more information about results of research into a drug’s effectiveness, as well as its possible risks.

Q: What could be proposed to weaken the bill?
A: A few key changes would make it less effective.

Law makers could propose amendments making it much harder to trigger quick action by the FDA when there are signs of danger, or prevent the FDA from being able to limit or moderate claims made in drug advertising about a new drug with serious safety problems.

Q: Won’t the bill slow approvals of new drugs?
A:  No

In addition to reauthorizing about $363 million annually in drug user fees to speed the drug-approval process, this legislation gives the FDA more tools to monitor drugs for safety once they are already on the market.  Drug approvals will continue through the same process as now the only difference is more information will be available to researchers, doctors and patients on the safety and effectiveness of those drugs once they are on the market, and the FDA will have more safety surveillance tools.

Q: Doesn’t the cost of these safety features detract from money for life-saving research?
A: No

User fees are increased $50 million annually to address and improve safety monitoring. With increased monitoring and early warning when there's a problem, drug companies and the FDA will be able to prevent national safety disasters like the deaths associated with Vioxx. By spending a small amount on improving safety, and preventing litigation from patients harmed by drugs, the pharmaceutical industry should have more money to fund important, life-saving research.

It is important to speed life-saving drugs to patients while also strengthening oversight of drugs post-market. We believe that with sufficient resources and authority, both goals are achievable through this legislation.

Q:  Won’t it cost too much to keep track of safety hazards as they emerge? 
A:  No.

Scientists already review side effects discovered in clinical trials as well as adverse reactions to a drug once it is on the market and used by millions. When a drug shows warning signs of dangerous risk, this bill will give the FDA the power to more quickly change a drug label and informing doctors and patients. With this new authority, it should no longer take the FDA months to change a label --in the case of Vioxx, for example, it took 14 months of negotiations with the drug maker to let patients and doctors know about the increased risk of heart attack or stroke.

Q:  Will the bill limit access to drugs people need?
A:  No

S. 1082 gives the FDA the authority to restrict the distribution and use of a drug only if the restrictions are commensurate with the specific risk the drug poses, and are not unduly burdensome on patient access, particularly for those patients with life-threatening diseases and patients who have difficulty accessing health care (such as patients in rural areas).

Q:  Aren’t restrictions on advertising unconstitutional?
A:  No

S. 1082 gives the FDA the authority to pre-review ads and to require that the ad disclose hazards. Failing to disclose serious risks in massive advertising campaigns could potentially harm millions of patients.

In very rare cases, the legislation allows the FDA to issue a temporary, two-year moratorium on ads for those new drugs that are approved despite serious safety questions.

The FDA learns a great deal about a drug after it has been widely marketed. For a drug with known safety risks from the start, common sense dictates an initial period of caution before large scale TV ads should be launched. The U.S. Supreme Court has outlined a stardard for commercial speech clearly applicable in this case (Central Hudson Gas & Electric Co. v Public Service Commission).