While Need For Greater Disclosure By FDA Is Evident, Drug Maker Trade Secrets May Be Difficult Obstacle To Overcome
(Posted by Tom Lamb at DrugInjuryWatch.com)
In early June 2009 it was announced that the FDA would begin to set up a task force within the agency whose purpose is to recommend ways by which there could be more timely disclosure about FDA regulatory and safety decisions.
From a June 2, 2009 FDA press release titled "FDA Forms Transparency Task Force" we get these laudable "sound bytes":
- Health and Human Services Secretary Kathleen Sebelius: "The Transparency Task Force will give the American people a seat at the table and make the FDA more open and accountable."
- FDA Commissioner Margaret A. Hamburg, M.D.: "I have asked the Transparency Task Force to deliver recommendations to me for ways to make more information available and foster better understanding of decision-making."
- Principal Deputy Commissioner Joshua Sharfstein, M.D.: "Implementation of the Transparency Task Force’s recommendations should make agency actions and decisions, and their underlying processes and bases, more transparent to the public."
This new FDA task force, which will be chaired by Principal Deputy Commissioner Sharfstein, consists of FDA center directors as well as the associate commissioner for regulatory affairs, chief scientist, and the chief counsel at the agency.
The FDA issued a June 3, 2009 Federal Register notice regarding the formation of its new Transparency Task Force in which the agency announced a June 24, 2009 public meeting intended to solicit recommendations on how the FDA can make more available, useful, and understandable information on its activities and decisions.
The agency has also established a "temporary" blog -- simply named "FDA Transparency Blog" -- which will run for the next six months, June through November 2009.
Two leading members of the medical community who have been involved with various drug-safety issues over time -- Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, and Dr. Catherine DeAngelis, editor of The Journal of the American Medical Association -- both impliedly endorsed this move by the FDA according to a June 2, 2009 article, "Drug Agency May Reveal More Data on Actions", by New York Times (NYT) reporter Gardiner Harris.
This same June 2 NYT article, however, points out that this new FDA task force will likely have a difficult time when it comes to the issue of any future disclosure of now secret data about drugs and devices under study:
The task will be complicated. Agency confidentiality decisions are governed by several interconnected laws, including the Federal Trade Secrets Act. Changing them would “involve more than one Congressional committee and impact thousands and thousands of companies, and thus would be an extremely difficult legislative path,” said Peter Barton Hutt, a former general counsel to the agency....
Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, said any agency plan to “disclose information about medicines during the F.D.A. review process should be carefully considered to ensure that the competitive development process remains intact to serve patients and the public health.”
According to the June 3 Federal Register notice, anyone interested in attending the June 24 public meeting -- which will be held at the National Transportation Safety Board (NTSB) Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594 -- must register by June 17, 2009.
The Federal Register notice also provides information about how to make written and electronic comments, which must be submitted by August 7, 2009.