Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

PHENYLPROPANOLAMINE DIET AID USE CRITICIZED IN HOUSE SUBCOMMITTEE MEMO issued by Rep. Wyden's (D-Ore.) Small Business/Regulation, Business Opportunities subcommittee in preparation for a Sept. 24 hearing on diet aids. Prepared by subcommittee staff, the memo notes that "FDA officials have informed staff that despite persistent medical community concerns regarding [phenylpropanolamine], the FDA is 'leaning' toward reaffirmation of its safe-and-effective finding" for OTC diet aid use. The memo adds that subcommittee staff "believe that this decision files in the face of experience with [phenylpropanolamine] in the current market setting." FDA announced at a May 7 hearing by the subcommittee that it was planning to publish a partial monograph banning 99 diet drugs. However, phenylpropanolamine has not been included in the list. "In the view of subcommittee staff," the memo states, "this is a mistake." "Medical authorities" have linked the drug to "dangerously high blood pressure, heart rhythm abnormalities, heart muscle damage, hallucinations, seizures and psychosis," the memo notes. According to the subcommittee memo, studies supporting phenylpropanolamine use are "seriously flawed" because "they are unpublished and without peer review, involve small numbers of subjects, repeatedly violate their own study protocols, and do not attempt the kind of follow-up needed to truly assess PPA's effect." Several witnesses at the hearing urged the ban of phenylpropanolamine-containing diet products from the market. National Association of Anorexia Nervosa and Associated Disorders President Vivian Meehan urged that phenylpropanolamine "be removed from over-the-counter availability and placed behind the counter or placed on a prescription basis only." Meehan declared: "Labeling must reflect the dangers of this drug in all its forms." Thaddeus Prout, MD, Johns Hopkins School of Medicine associate professor, said that "what is needed is a way to prevent the use of medications by a large segment of the population for whom their use is inappropriate." He added: "FDA should look again at the large number of 'anecdotes' that have been generated by this medication. It is by no means clear that [phenylpropanolamine] is an essential agent in our armamentarium for the symptomatic control of minor complaints. It is becoming increasingly clear that the removal of this medication from the market entirely would not leave a deficit of any kind." Michigan State University professors L.R. Krupka and A.M. Vener reported on 1982 and 1984 diet product surveys they conducted showing widespread use of phenylpropanolamine diet pills among teenage women. "Our data clearly show that users of diet pills are frequently under the age of 18, with some starting usage at age 12. Our data also indicate that a number of young people ingest more than the recommended 75 mg of [phenylpropanolamine] within a 24 hour period," the researchers said in jointly prepared testimony.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts