Rejected Drugs May Be Disclosed by FDA for First Time

Drug rejections, plant inspections and detailed side-effect reports would be shared with consumers for the first time under a new plan from U.S. regulators.

The Food and Drug Administration proposed 21 steps today to expand the public’s knowledge of medicines, medical devices, food and cosmetics, including when they fail to meet federal standards. Public comments on the proposals will be accepted until July 20.

Lawmakers, doctors and consumer groups criticized the FDA under former President George W. Bush for failing to disclose heart risks with GlaxoSmithKline Plc’s diabetes pill Avandia and Merck & Co.’s painkiller Vioxx. The FDA created a Transparency Task Force in June in response to the Obama administration’s call for government agencies to be more open with information.

“We should have done this a long time ago,” said Scott Gottlieb, a partner at Arcoda Capital and American Enterprise Institute fellow who served as the FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007. “The public deserves to see the agency’s explanations for its decisions.”

The task force, led by FDA Principal Deputy Commissioner Joshua Sharfstein, recommended that the agency start disclosing when products are tested in people, submitted for marketing authorization, withdrawn or denied approval. This would include releasing so-called complete response letters sent to drugmakers explaining why their products are rejected.

Secret Letters

These letters are now secret, and most companies only summarize their content in communications to investors. The agency usually refrains from commenting at all on products before approval.

John Jenkins, head of the FDA’s Office of New Drugs, said in December that 70 percent of drug applications are missing information and exposing the deficiencies may encourage companies to be more thorough.

“Any proposal to disclose information about medicines during the FDA review process should be carefully considered to ensure that the competitive development process remains intact to serve patients and the public health,” the Pharmaceutical Research and Manufacturers of America, a Washington-based trade group, said today in an e-mailed statement. “We welcome a continued dialogue with regulatory authorities and stakeholders about these important matters.”

The Biotechnology Industry Organization is still reviewing the report and wasn’t available for comment.

Need for ‘Balance’

“Trade secrets should remain confidential and such information should be redacted from documents proposed for disclosure,” Sharfstein said today. “The proposals reflect what the task force believes is an appropriate balance for the agency to strike between disclosure and confidentially in support of public health, clinical practice and innovation.”

The task force also recommended that the FDA release the name, address and result of inspections of clinical trials and facilities that make or process regulated products. Inspection reports are now generally only released under the Freedom of Information Act unless they present consumer-health issues, such as with Johnson & Johnson’s April 30 recall of pediatric drugs.

The agency should also expand public access to reports of side effects submitted on its website, the task force said.

The proposals are the second part of a three-phase initiative and follow two public meetings and more than 1,500 public comments. Sharfstein said on a conference call that the agency will review what new authorities or funding from Congress would be necessary to implement these changes after the 60-day public comment period.

Public Citizen

FDA officials proposed releasing data on experimental drugs in 1977 but the Federal Food, Drug, and Cosmetic Act was never amended to allow this to happen, said Sidney Wolfe, director of Public Citizen’s health research group in Washington. The consumer group has sued the FDA for access to its reviews of medicines found to pose safety risks or be ineffective.

“How many more decades are going to go by before this issue is addressed?” Wolfe said today in a phone interview. “Instead of having to keep litigating it on a case-by-case basis, it would be nice if they did something to change it.”


Before it's here, it's on the Bloomberg Terminal. LEARN MORE