The FDA Transparency Task Force drafted 21 recommendations to increase the agency's transparency with regard to drug regulation - including providing more information on drug rejections, plant inspections, and safety and side effect information. The agency is now in a 60 day period seeking public response. See full report of the agency's intentions and actions to date in the New England Journal of Medicine.
Among the 21 recommendations are proposals to publish more information on drugs that are rejected by the agency including full text of agency response letters. This is not only interesting to consumer groups but analysts and investors like to see full text to prevent company spin.
There is also a proposal to provide agency site inspections reports including site addresses and whether any Official Action, Voluntary action or No Action was indicated. The agency should share with the public the most common objectionable conditions or practices found in these inspections.
One of the more interesting proposals deals with Orphan drugs. This proposal suggests that when an orphan drug proposal is abandonned or terminated that the FDA indicate whether or not this was done for safety reasons. The agency is also asked to state whether or not the drug, if pursued, would represent an advance in patient treatment for this orphan disease in question. It is basically asking the agency to identify cases where the drug may have been dropped for business reasons and not safety. The agency could effectively encourage another firm to pick up the drug for development.
The FDA would also be asked to disclose relevant safety and effectiveness information on on investigational applications or for those seeking market application - if agency concludes it is in the public safety interest. This is particularly true if the agency believes this additional disclosure will help correct "misleading information about the product that is the subject of the application".
For full text of the Download FDA Transparency proposals.
Reactions are varied:
Scott Gottlieb, partner at Arcoda Capital and American Enterprise Institute Fellow, says "We should hav edone this a long time ago. The public deserves to see the agency's explanations for its decisions"
PhRMA official statement "Any proposal to 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".
Of course, investors, analysts and competitors to name a few will be anxious to see this information. Joshua Sharfstein, the Task Force's Head, hastens to add that trade secret information will be withheld. He also notes that not all of the recommendations will be implmented and that some would require legislative action to be implemented.
References & More Information
Bloomberg.com Rejected drugs may may be disclosed by FDA for first time.
Boston.com FDA plan would share drug rejections.
WSJ - Health FDA to disclose more details on drug, food safety.
thepharmaletter FDA Transparency Task Force unveils draft proposals for more public disclosure relating to pharma
Fierce Biotech FDA proposes controversial release of complete response letters.
Biopharma Life FDA proposes far-reaching transparency initiative; public peek at industry R&D failures.
FDA Gov site FDA Transparency Task Force
Posted by Bruce Lehr May 23rd 2010.
Comments