FDA Names and Shames Drug Makers to Encourage Generic Competition


While Celgene tops the list, other companies that the F.D.A. named as the subject of complaints included GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, and BioMarin Pharmaceutical.

Celgene, which makes drugs to treat cancer and immune-inflammatory diseases, was named as the subject of 31 inquiries from companies seeking access to Revlimid (lenalidomide), its treatment for multiple myeloma and related diseases; Pomalyst (pomalidomide); and Thalomid (thalidomide).

Celgene has been embroiled in lawsuits for several years with companies seeking access to the drugs. It recently sued Dr. Reddy’s Laboratories Ltd., an Indian company, to block it from selling generic copies of Revlimid, the company’s biggest product, and has been fending off an attempt by Mylan to also get into the generic Revlimid business. At a court hearing last year, a lawyer for Mylan, Jonathan M. Jacobson, told a federal district judge that the drug costs dying patients $20,000 a month — a price that would decline if generics were available.

The next biggest target, with 26 inquiries, is Actelion Pharmaceuticals Ltd., a Johnson & Johnson company, which is accused of blocking access to four drugs. There were 14 inquiries about 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), which is also used to treat pulmonary arterial hypertension. There were also several complaints about a lack of access to Actelion’s Zavesca (miglustat) and Veletri (epoprostenol sodium). Veletri is also used to treat pulmonary arterial hypertension and Zavesca is indicated for Gaucher disease.

An average one-month supply of Tracleer costs just over $12,000, and a supply of Opsumit runs $8,900 to $10,000, according to GoodRx, which tracks drug prices. Both prices are based on the patient presenting a free discount coupon.

Other companies the F.D.A. listed as reluctant to provide samples are Gilead Sciences Inc. and Novartis Pharmaceuticals Corporation.

Many pharmaceutical companies sell both brand-name and generic drugs, leading to a situation in which a company like Mylan, still fighting Celgene in court, can be on the receiving end of generic company complaints.

The F.D.A.’s list of shame notes three inquiries from companies trying to get access to Mylan’s Amnesteem (isotretinoin), used to treat severe cystic acne that has not responded to antibiotic treatment.



Source link

Leave a Reply

Your email address will not be published.