News from the PDUFA reauthorization front: The FDA met with biopharma industry reps 112 times while reviewing drug policies while setting aside time for a total of five meetings with patient and consumer groups. BIO and PhRMA reps appear to have commanded the most quality time with the agency, which has been pushing Congress hard to reauthorize drug industry fees that are tied to agency deadlines on drug approvals. Critics used the information to highlight the "cozy" relationship biopharma enjoys with the FDA. For its part, the agency said it had a number of technical issues to work out on PDUFA that required the meetings.
- check out the report [1] from USA Today
ALSO: Is the FDA emphasizing speed over safety? Report [2]
Related Articles:
FDA chief defends collaboration in drug development. Report [3]
FDA offers safety reforms to skeptical lawmakers. Report [4]
Senate toughens drug safety supervision in PDUFA bill. Report [5]
Congress juggles two crucial drug bills. Report [6]
FDA, drug industry re-negotiate user fees. Report [7]
Links:
[1] http://www.usatoday.com/news/health/2007-06-11-fda-drugmakers_N.htm
[2] http://www.fiercehealthcare.com/story/fda-emphasizing-speed-over-safety/2007-06-12
[3] http://www.fiercebiotech.com/story/fda-chief-defends-collaboration-in-drug-development/2007-05-31
[4] http://www.fiercebiotech.com/story/fda-offers-safety-reforms-to-skeptical-lawmakers/2007-01-31
[5] http://www.fiercebiotech.com/story/senate-toughens-drug-safety-supervision-in-pdufa-bill/2007-05-10
[6] http://www.fiercebiotech.com/story/congress-juggles-two-crucial-drug-bills/2007-05-01
[7] http://www.fiercebiotech.com/story/fda-drug-industry-re-negotiate-user-fees/2006-11-21