While Celgene leads the list, other companies say that the F.D.A. The complaint objects include GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences and Novartis Pharmaceuticals
Researchers are looking at companies seeking access to Revlimid (lenalidomide), their treatment for multiple myeloma and related diseases; Pomalyst (pomalidomide); and thalomide (thalidomide).
Celgene has been involved in litigation with companies seeking access to drugs for several years. Recently, Dr. Reddy's Laboratories Ltd., an Indian company to block the sale of generic copies of Revlimid, the company's largest product, opposed an attempt by Mylan to enter the generic Revlimid business. At a trial last year, a lawyer for Mylan, Jonathan M. Jacobson, a federal district judge, said the drugs cost patients $ 20,000 a month ̵
Greg Geissman, a spokesman for Celgene, said the company did not stop generic drug companies from getting their products.
"We have sold our breakthrough products to generic drug manufacturers and will sell them for the purposes of bioequivalence testing, subject to reasonable safety and business requirements." Mr. Geissmann said. "Generic versions of Thalomid and Revlimid are expected to be launched in the next few years."
Geissman also said that Celgene is supporting federal efforts to promote access to samples at reasonable prices as long as there is adequate safety and liability protection
The next major target with 26 inquiries is Actelion Pharmaceuticals Ltd., a A Johnson & Johnson company accused of blocking access to four drugs. There were 14 requests for supplies of Tracleer (bosentan), a medication prescribed for high blood pressure in the lungs, known as pulmonary arterial hypertension. The F.D.A. Also, eight complaints about lack of access to Opsumit (macitentan), which is also used to treat pulmonary arterial hypertension. There were also some Complaints about a lack of access to Actelions Zavesca (miglustat) and Veletri (epoprostenol sodium). Veletri is also used to treat pulmonary arterial hypertension, and Zavesca is indicated for Gaucher disease.