FDA task force calls for more disclosure of drug, device information

A Food and Drug Administration task force in May unveiled a series of 21 proposals to share publicly more information about pending or rejected drug and device applications, as well as agency enforcement actions. The move, which has drawn objections from companies fearful that greater disclosure will spill trade secrets, is part of a larger transparency drive the FDA launched last year.

"The goal of this initiative was to better explain the FDA's actions by providing information that supports clinical medicine, biomedical innovation, and public health," according to a May 19 New England Journal of Medicine commentary about the plan authored by Joshua M. Sharfstein, MD, principal deputy commissioner of the U.S. Food and Drug Administration and chair of the Transparency Task Force, and Afia K. Asamoah, director of the FDA's Transparency Initiative.

Among other things, the agency said in a report outlining the initiative, the proposals would allow the FDA to:

• Disclose copies of the letters the agency sends to companies when it rejects a new product application.
• Release summary data on the safety and effectiveness of pending product applications to "clear misconceptions or promote public health."
• Post information about every agency inspection of manufacturers' plants.

The agency said the new disclosure plan will not share trade-secret information about the drugs and devices it is evaluating, but drugmakers expressed concerns. While welcoming more transparency at the FDA, Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson sounded a note of caution.

"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," Johnson said.

Peter S. Reichertz, a partner in the law firm of Sheppard Mullin Richter & Hampton in Washington, D.C., who represents many smaller, nonpublic drug and device firms, said the new transparency proposals could especially hurt his clients. Publicly traded companies already must frequently disclose information about their FDA interactions in Securities and Exchange Commission filings, he said. The same is not true of the firms he represents.

"I don't really find the FDA's discussion of trade secrets very persuasive in terms of the clients I represent and how they treat their development plans, which would also include all the stuff that happens up until the time of their approval," Reichertz said. "Sometimes, FDA letters in response to an application are given a lot more weight than they're entitled to. They may raise issues that aren't really issues, before the company has time to respond to it. If this stuff gets out there and is made public, it will make it harder for smaller, nonpublicly traded companies to develop products."

Collaboration, not competition

Other experts said more transparency could help both the industry and the public.

The FDA should be careful to redact any proprietary product information before disclosing its actions publicly, said Scott Gottlieb, MD. But if it does so, he said, greater transparency will give investors more confidence and ultimately aid biomedical innovation.

"The public has a right to know what a federal agency is telling companies about their products on the market or in clinical development," said Dr. Gottlieb, who served in various FDA capacities from 2003 to 2007 and now works as an adviser to, and as an investor in, health care companies. "I think it's in the industry's longer-term interest to have that [information] made public. The fact that the information is not made public leads to a lot of uncertainty, in the biotech industry in particular. It creates opportunities for companies to misrepresent facts to investors and leaves investors unwilling to invest in biotech."

Physicians may get more questions from patients who are confused or worried about FDA-disclosed news regarding unapproved products, Dr. Gottlieb said. But in the long run, he added, doctors and patients will benefit from a more open approval process for drugs and devices.

The FDA's transparency proposals are laudable because they put the public's health before any one company's profits, said Maggie Mahar, health care fellow at the Century Foundation, a liberal think tank in New York City.

"What the FDA is really saying is that the whole purpose of this [transparency] exercise is to protect patients and make them healthier -- it's not to support market competition," said Mahar, author of the 2006 book, Money-Driven Medicine: The Real Reason Health Care Costs So Much. "Market competition is fine, but the agency is less interested in a competitive market than a collaborative market, where drugmakers and device-makers can learn from their competitors' mistakes and failures."

It is unclear which, if any, of the proposals will be put into action. Leaders of the FDA's transparency initiative said some of the recommendations require new laws or regulations, while others require more funding. The deadline for comments on the transparency proposals is July 20.