Congressmen Call for Report on New Class of Drugs - Pharmaceutical Technology

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Congressmen Call for Report on New Class of Drugs


ePT--the Electronic Newsletter of Pharmaceutical Technology

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Washington DC (Jan. 21)—Congressmen John Dingell (D-MI) and Bart Stupak (D-MI) have requested that the Government Accountability Office (GAO) perform an updated assessment in response to the US Food and Drug Administration’s potential development of a new class of behind-the-counter (BTC) drugs, according to the Jan. 21 edition of Drug Industry Daily.

In a letter to GAO Comptroller General David Walker, the congressmen requested that more information be gathered in order to assess the benefits, risks, and general necessity of any new class of BTC drugs. In an August 1995 report, GOA evaluated the experience of other countries with BTC drugs, and found insufficient evidence to support the establishment of a new class of BTC drugs in the United States. The US representatives’ letter to Walker suggested that the gathering of new data was necessary; however, the new report would not have to include an investigation of other countries with similar BTC drug programs.

According to Drug Industry Daily, the potential new class of drugs being evaluated by FDA would be those drugs deemed to not require a doctor’s prescription but would need the approval of a pharmacist to purchase. Although no FDA proposal has been presented regarding the creation of a new class of BTC drugs, opponents suggest the new class may raise drug costs. Supporters of BTC drugs suggest that today’s patients are more informed about their health and that an individual’s access to drugs would improve without the need of a doctor’s prescription.

The potential new class of BTC drugs could include oral contraceptives, over-the-counter children’s cough and cold medicines, Tamiflu, and epinephrine injections.

Rep. Dingell is the Chairman of the House Committee on Energy and Commerce and Rep. Stupak is the Chairman of the Oversight and Investigations Subcommittee.

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