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

"FOUNTAIN OF YOUTH" DRUG IMPORT RING IS UNDER FEDERAL INDICTMENT, announced March 16 by the San Diego U.S. Attorney's office, FDA and the U.S. Customs Service. The indictments charge a California-based organization with illegally importing into the U.S. approximately $5 mil. worth of so-called "new age" life extension products over the last five years. The multi-year, international investigation resulted in 198 indictments against five individuals and five companies, including the alleged ringleader, David Halpern of Pebble Beach, Calif. The more than 15 tons of illegally imported products -- various cell therapies, derivatives of procaine HCl and sexual tonics -- have been promoted for a variety of diseases, including depression, senility, diabetes, rheumatoid arthritis, cataracts and radiation damage, the Southern California U.S. Attorney, William Braniff, told a March 16 press conference in San Diego. The cell therapies, derived from animal organs and tissues, are sold for injection on the U.S. black market for over 100 medical conditions, including Graves disease, arteriosclerosis and hypertension, the press briefing was told. FDA warned that use of the products could result in serious adverse health consequences, including the possible contraction of animal diseases such as Q- fever or brucellosis. The procaine HCL derivatives, sold as GH3, KH3 and Gerovital in tablet and injectable forms, were being promoted as rejuvenation products and for the treatment of conditions including neuralgia, Parkinson's disease and hypertension. Injectable procaine is approved in the U.S. only as an anesthetic. Possible side effects from continued use of the drug for anti- aging include the potential for anaphylaxis. The sexual tonics, imported from codefendant Zumba Vertriebsgesellschaft Pharmazeutischer Erzeugnisse GmbH, Germany, contain yohimbine and methyltestosterone, both of which may cause serious adverse reactions. The products were imported for commercial sale on the so- called "new age" life extension products black market through wholesalers, health food and natural food stores and nutrition centers, gymnasiums, chiropractors and individuals, FDA said. The products were being sold in 43 states, Canada, Guam and the Virgin Islands. FDA noted that it will seek to seize any large quantities of comercially sold "fountain of youth" drugs uncovered by the agency. FDA also pointed out that the indictments in no way alter its longstanding policy of allowing importation of foreign- approved drugs for personal use. The indictments follow another recent high-profile crackdown by FDA on the illegal import of drugs into the U.S. As part of FDA's get-tough enforcement stance, on Jan. 30 the agency imposed an import alert on six foreign companies that offered mail-order drugs that were either unapproved in the U.S. or counterfeit ("The Pink Sheet" Feb. 10, T&G-13). The drugs in question were for a variety of medical conditions, including hypertension, depression and neuropharmacological ailments.

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

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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