To prove a generic drug is as safe and effective as the branded version, pharmaceutical companies have to hand over upwards of 1,000 doses of the product to a generic developer.
But if the manufacturer creating the generic drug cannot get its hands on enough sample, the development and testing process slows down. It could potentially even keep a generic version of the drug from ever reaching the market.
If companies developing generics have trouble accessing the samples they need, they can file a complaint with the FDA. Today, the FDA published a list of 39 pharmaceutical companies that have been the subjects of such complaints.
Celgene (NSDQ:CELG) was at the top of the list with 31 complaints from generic manufacturers. Others that made the list included Novartis (NYSE:NVS), Gilead Sciences (NSDQ:GILD), GlaxoSmithKline (NYSE:GSK), Valeant Pharmaceuticals (NYSE:VRX) and Johnson & Johnson‘s (NYSE:JNJ) Actelion.
In total, the agency has received more than 160 inquiries from generic drugmakers complaining that they can’t get enough sample. The list will be updated on a “semi-annual” basis, according to the website.
“As part of the FDA’s Drug Competition Action Plan, FDA is committed – among other things – to addressing and improving transparency about this and other gaming tactics that delay the generic competition Congress intended,” the FDA wrote.
Pharmaceutical companies have defended their actions, arguing that they often withhold drugs for safety purposes. Take Celgene, for example – one of the drugs that generic developers have had trouble accessing is Celgene’s thalidomide product, which is designed for patients with multiple myeloma. But Celgene pointed to thalidomide’s well-characterized dangers as part of the reason it can’t just fork over the product.
“Since we introduced these products, those rigorous safety measures have ensured the safe use of these medicines without a single birth defect of the type associated with thalidomide,” the company reportedly said.
Gottlieb has repeatedly called on pharmaceutical companies to quit what he calls “gaming tactics” – strategies used by brand-name drugmakers to game the system and stave off competition from generics.
“We’ll continue to look at more ways we can expand upon today’s action and call public attention to situations where the careful balance that Congress sought between product innovation and access may be being disrupted,” Gottlieb said in prepared remarks. “We’ll also continue working with the FTC where there may be anticompetitive business practices at play. And we’ll continue to strengthen our internal processes for handling inquiries related to problems generic drug developers report having in obtaining samples of brand products.”
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