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F.D.A. Makes Public Generic-Blocking Practices of Drug Companies

— May 29, 2018

F.D.A. Make Public Generic-Blocking Practices of Drug Companies

While Celgene tops the list, other companies that the Food and Drug Administration (F.D.A.) named as the subjects of complaints regarding generic-blocking practices include GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences and Novartis Pharmaceuticals.

“I don’t think this is publicly shaming,” Dr. Scott Gottlieb, commissioner of the FDA said of the agency’s decision to make the blocking practices public.  “I think this is providing transparency in situations where we see certain obstacles to timely generic entry.”

However, Gottlieb had a different outlook during a May 25, 2017, congressional hearing, in which he said he was “happy to work” on “a shaming initiative.”  This comment was in response to Rep. David Young, R-Iowa, who noted that: “There is a power in shaming. Sunlight is the best disinfectant to put people in place and to try to get to a better behavior.”

In any case, the FDA’s website spotlights the tactic of brand-name drug makers to withhold samples of their drugs from generic drug makers.  Gottlieb said he hopes by providing this information, the agency will be able to dig up the “root cause” of the issue and squash bad behavior.  “And if it does, I think that’s a useful public health outcome,” he explained.

Photo by Hush Naidoo on Unsplash

Celgene, which makes drugs to treat cancer and immune-inflammatory diseases, was named as one of the top problematic companies, with 31 inquiries from businesses seeking access to Revlimid (lenalidomide), its treatment for multiple myeloma and related diseases; Pomalyst (pomalidomide); and Thalomid (thalidomide).  Celgene has been hit hard with lawsuits for several years with companies seeking access to the drugs.  It recently sued Dr. Reddy’s Laboratories Ltd. in order to block it from selling generic copies of Revlimid and has been fending off an attempt by Mylan to also begin selling a generic version of the same drug.   At a court hearing last year, an attorney for Mylan, Jonathan M. Jacobson, told a federal district judge that the drug costs dying patients $20,000 a month.  Generics would help alleviate this astronomical price.

Greg Geissman, a spokesman for Celgene, said the company had not prevented generic companies from obtaining their products.  “We have sold and will sell our groundbreaking products to generic manufacturers for the purposes of bioequivalence testing, subject to reasonable safety related and business requirements,” Mr. Geissman said. “Generic versions of Thalomid and Revlimid are expected to enter the market in coming years.”  He also indicated that Celgene supports federal efforts to promote access to reasonably-priced samples.

The next biggest target is Actelion Pharmaceuticals Ltd., a Johnson & Johnson company, which is accused of engaging in practices to block access to four of its brand name drugs.  Fourteen of 26 total inquiries were related to getting supplies of Tracleer (bosentan), a medication prescribed for high blood pressure in the vessels of the lungs, known as pulmonary arterial hypertension. The F.D.A. also received eight complaints about lack of access to Opsumit (macitentan), used to treat the same condition. There were several complaints about a lack of access to Zavesca (miglustat) for Gaucher disease and Veletri (epoprostenol sodium), used to treat pulmonary arterial hypertension.


F.D.A. Names and Shames Drug Makers to Encourage Generic Competition

FDA has named names of pharma companies blocking cheaper generics [Updated]

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