Generic Drugs
For additional information on this topic please see our article "Branded" Generic Drugs".
Please also see our article "Patents and the Possibility of Generic Biologic Drugs"- Part III of a III Part Series
(9/23/08)- The U.S. Food and Drug Administration banned imports of more than 30 generic drugs made by Ranbaxy Laboratories Ltd., of India, because of concerns about the "seriousness and extent" of violations at two Ranbaxy plants in India. Consumers will not be affected by the bans because the drugs can be supplied by other generic drug makers, with the exception of the company's AIDS drug called Ganciclovir for which the company is the sole supplier in the United States.
Ranbaxy is the largest generic drug manufacturer in India with worldwide sales of $1.62 billion in 2007, of which $400 million took place in the U.S. The Japanese drug company Daiichi Sankyo Co., is in the process of taking over Ranbaxy in a $4.6 billion deal that is awaiting Indian governmental approval.
Ranbaxy is presently under investigation by the U.S. Justice Department for allegations of improperly manufacturing HIV drugs that were given to thousands of AIDS patients in Africa.
It is unclear whether the ban might affect Ranbaxy's six-month exclusivity deal to produce Lipitor, Pfizer Inc.'s blockbuster cholesterol drug that comes off patent protection in 2011
Indian pharmaceutical exports are projected to hit $10 billion this year, up from $1.9 billion in 1999, according to Global Trade Information Systems, a U. S. supplier of international trade data, and IDFC-SKKI Securities, a Mumbai brokerage firm.
(5/2/08)- Melinda Beck wrote a recent article in the Health Journal column of the Wall St Journal entitled "Inexact Copies: How Generics Differ From Brand Names"
In the article Ms. Beck discusses the fact the human body may have different reactions to generic drugs from their reaction to brand name drugs. A main part of the article discussed what has what happened after Wellbutrin, the antidepressant drug made by Biovail Corp. of Canada, and marketed by GalxoSmithKline PLC of England, the generic version of this drug, named Budeprion XL 300 came onto the market. Budeprion XL is distributed by Teva Pharmaceuticals USA, the American subsidiary of the Israeli generic drug company Teva Pharmaceuticals.
The FDA approved a Budeprion XL in December 2006, and the drug immediately impacted the sales of Wellbutrin. The article pointed out, "But patients soon started logging complaints about Budeprion at PeoplesPharmacy,com, a Web site that has become a clearing house for medication gripes."
Joe Graedon, a pharmacist who runs People's Pharmacy with his wife alerted the FDA and also asked ConsumerLab.com to run a test on Budeprion. Consumer Labs found that Budeprion dissoves faster, releasing 34% of the drug within the first two hours, compared with 8% for Wellbutrin.
Generics must have the same bioequivalency as the brand name drug, and thus they avoid the strenuous testing requirements that the FDA imposes before it will approve a drug for usage in the market. According to FDA guidelines the generic can produce blood levels as much as 20% below or 25% above the branded drug.
According to data from the Generic Pharmaceutical Association, a trade group for the generic drug industry, about 65% of all prescription drugs dispensed are for generic versions of the drugs.
The FDA conducted an investigation of the Wellbutrin matter and found that there was only "small differences" between it and the generic drug. Critics of the FDA report however said that the FDA relied on tests comparing a lower dosage of Wellbutrin and Budaprion- 150 mg-when it first approved the 300 mg version in 2006. The agency therefore did not have specific bioequivalence data on the 300- mg dose that had generated the complaints.
Bioequivalence tests are conducted on healthy people, not those who need the medication, according to FDA officials.
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Allan Rubin
updated September 23, 2008
http://www.therubins.com
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