Personal Injury Law

FDA - How Much Does The Public Need (Want) To Know?

By Jane Akre

FDA May Become More Transparent

The public has an opportunity to tell the Food and Drug Administration (FDA) how much information it wants about safety problems with drugs, food manufacturing and medical devices.

The FDA's Transparency Task Force issued 21 draft proposals which would make the FDA more accountable to the public by disclosing how and why it makes decisions.

The proposals will be published in the Federal Register this week, are part of a bigger initiative under Commissioner Margaret Hamburg to press for an 'unprecedented level of openness in Government.'

The agency still must balance the need of companies to preserve trade secrets and the agency to effectively launch enforcement actions.

The FDA has been accused of making decisions in secret about a quarter of the gross national product, from food additives and frozen pizza to flu drugs and defibrillators.

The proposals include:

* Elaborate on FDA decisions- the FDA would publish rejection letters in response to a new drug or device applications explaining what led to the decision

* Provide Increased Access to Important Data – disclose safety and effectiveness from a drug application

* Illuminate Enforcement Efforts – name and address of inspection facility, findings and enforcement action

Public Citizen's Dr. Sidney Wolfe commended the proposal. 'You can talk about transparency from here to eternity and if you don't have an actual mechanism to make that data available it becomes less meaningful' he said reports ABC News.

Problems in the Past

A good example of a lack of transparency is the drug, Vioxx, the popular painkiller taken off the market in 2004 after being linked to heart attacks and strokes. Critics say that lives could have been saved if the FDA had told what it knew and when it knew it.

"Our goal is to facilitate transparency that promotes public health and innovation," said Joshua Sharfstein, FDA principal deputy commissioner and chair of the Transparency Task Force. "These proposals reflect a careful balancing of the importance of transparency with the importance of protecting trade secrets and confidentiality."

Sharfstein, along with the Director of the Transparency Initiative, Afia Asamoah outlined the proposal in the New England Journal of Medicine (NEJM).

Some of the proposals may require Congress to change laws to implement and the FDA may not adopt all of the proposed changes. The FDA has initiated a blog as part of the transparency effort, and invites the public to comment for 60 days. So far more than 1,500 comments have been received.

The draft proposal begins with this reminder:

[G]overnmental decisions, particularly regulatory decisions, should be based on publicly available information. . . . This premise underlies the Freedom of Information Act, the Federal Advisory Committee Act, and the Government in the Sunshine Act. In enacting each of these statutes, the Congress implemented a basic principle of our political system: that people affected by governmental decisions have a right to know the basis on which they are made. Anyone who questions the wisdom of a regulatory decision should be able to examine the factual foundation of the decision.

FDA Commissioner Donald Kennedy, 1978

The first phase of the transparency initiative was completed in January 2010 with the launch of a web-based resource called FDA Basics (http://www.fda.gov/fdabasics).#

Full post as published by InjuryBoard on May 20, 2010 (boomark / email).