FDA To Hold Meeting On Behind-the-Counter Drug Classification; Some Researchers Concerned About New FDA Center

Main Category: Pharmacy / Pharmacist
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals;  Public Health
Article Date: 16 Oct 2007 - 10:00 PDT

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Summaries of two recent developments related to FDA appear below.

• BTC classification: FDA next month plans to hold a meeting of stakeholders to consider the possibility of a behind-the-counter classification for medications, CongressDaily reports (Edney, CongressDaily, 10/15). Medications classified as BTC -- a status that would apply to some treatments currently available only with a prescription -- would not require a prescription from a doctor, but pharmacists would have to verify that customers meet certain criteria and instruct customers on proper use of the medications (Kaiser Daily Health Policy Report, 10/4). Congress likely will make the final decision about whether to allow a BTC classification, according to former FDA officials and pharmacy experts (CongressDaily, 10/15).
  
  
• Reagan-Udall Foundation: FDA continues to move with "unprecedented speed" to launch the Reagan-Udall Foundation, a new research center that will "be paid for by companies it regulates," the AP/Atlanta Journal-Constitution reports. The foundation, established under a legislation signed into law on Sept. 27, seeks to improve the development of medications and medical devices. On Oct. 3, FDA filed a public notice to seek applications for foundation board members. FDA plans to announce the foundation board members on Oct. 27 (Perrone, AP/Atlanta Journal-Constitution, 10/14). The 14-member foundation board must include three academics, two consumer advocates, one health care provider, four industry representatives and four "at-large" members with "experience relevant to the purpose of the foundation." Some critics have raised concerns because private donations from food, pharmaceutical and medical device companies in large part will fund the foundation (Kaiser Daily Health Policy Report, 10/4). Francesca Grifo, a director at the Union of Concerned Scientists, said, "Given FDA's track record in the past, I'm not confident in their ability to create something that is free of influence from industry," adding, "Time and again we've seen that people within FDA behave as if industry is their primary client" (AP/Atlanta Journal-Constitution, 10/14).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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