QDIS Blog

This past week thee were two interesting hearings on the safety of both food and drugs.

PharmaLive: Sen. Enzi Holds Hearings on Food and Drug Safety

Given the number of instances lately that have received media attention (Vioxx and the e coli 0157 problems with spinach) I think this is timely. What follows are my thoughts, comments and interesting points on the drug safety hearing made while watching it.

Ms Burke of Institute of Medicine
• General feeling of the need giving the FDA more authority to ensure safety
• Need for new tools to predict safety.
• Central clearing house for clinical trials information
• S 3807 closely parallels many of the suggestions in the Institute of Medicine Report released in Sept.
• FDA scientists may have been pressured to change recommendation based on politcal views according to Senator Ted Kennedy
• $6 per year for every American is what the FDA budget comes to even though they oversee about 25% of the GNP
• A life-cycle approach to drugs should be taken including post-marketing studies
• The CEDR organizational structure is sometimes dysfunctional.
• A major need for leadership and stability.
• Recommendation to make the FDA Commissioner a fixed 6 year appointment.
• Recommend entirely funding from congressional budget and curtailing use of PUDFA.

This is interesting since this model is being proposed for reviewing ads for approved drugs.

• IOM committee did not think breaking up CEDR into one for approval and one for safety made sense. Did want to get post marketing folks involved earlier in the process.
• Legislation will NOT force cultural change. This is why leadership is critical.
• IOM had many recommendations especially with regard to ways to possibly integration various divisions and to change the culture.
• FDA ability to unilaterally change labeling was discussed.
• Appropriations should be primarily but PUDFA funds are needed these should also be made available for post-marketing
• IOM did not want to comment on biogenerics. Senator Hatch pursued this quite extensively.
• Senator Patty Murray brought up concern of politicalization of scientific information within the FDA.
• Statues need to be given to the FDA to unilaterally make changes to labeling. This came up several times.
• DTC ads were discussed and are needed but need to be informative to the consumer. They should be easily understood.
• Senator Clinton asked about comparative effectiveness studies. Nothing was really offered in this regard.

2nd segment; five people testified
• Clinical trial registries were discussed by several people giving testimony.
• Better funding was mentioned by almost all.
• In this part, sometimes questions asked and answered led to more questions in my mind but the Senators never seemed to follow up on what the people testifying really meant. There should be more follow-up questions in my opinion. Sometimes it seemed the clock was more important than the content of the meeting.
• No one was in favor of separating safety from approval within the FDA.

One last comment. I truly believe all government hearing should be easily available online in video as well as pdf version of the statements.

Other Resources

• Full Committee Hearing Hearing - Hearing on Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation (includes links to pdf files of witness testimony)

• Video of hearing (Real Player: begins at 35:04: ~1 h 54 min in length)

• Full Committee Hearing on Food Safety: Current Challenges and New Ideas to Safeguard Consumers (includes links to pdf files of witness testimony)

• Video of hearing (Real Player: begins at 17:47: ~x h y min)

• Ted Kennedy | S. 3807, The Enhancing Drug Safety and Innovation Act of 2006

Technorati Tags: drug safety, FDA, food safety

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