FDA calls out drugmakers to promote greater generic competition
The U.S. Food and Drug Administration on Thursday called out 39 drugmakers for potentially blocking access to their drug samples in an effort to delay generic competition.
In an announcement singling out Celgene, Johnson & Johnson subsidiary Actelion and Gilead Sciences among others, FDA Commissioner Dr. Scott Gottlieb said the agency had heard that pharmaceutical companies are engaging in tactics to forestall generic drugs from hitting the market.
One of those tactics involved refusing to sell, or imposing unreasonable sale conditions on, samples of branded pharmaceuticals to generic-drug makers. Generic companies must obtain these samples and perform clinical studies to secure FDA approval of their products. The agency said a drug developer generally needs from 1,500 to 5,000 units of the brand drug for such purposes.
Gottlieb said regulators had received more than 150 inquiries from generic drug developers for federal assistance to obtain branded drug samples.
In some cases, Gottlieb said drugmakers restricted prescription drug distributors, wholesalers or specialty pharmacies from selling branded samples to generic drug developers for testing.
"I want to be very clear: a path to securing samples of brand drugs for the purpose of generic drug development should always be available," Gottlieb said in a statement.
Celgene was the subject of the most product inquiries, with 31 generic drug company complaints over their ability to acquire samples of three of Celgene's best-selling drugs. Thirteen of the complaints involved its cancer drug Revlimid, which generated more than $8 billion in sales in 2017 and accounted for 62% of Celgene's total revenue that year, according to an analysis of the company's financial statement.
Generic companies made 10 inquiries about Celgene's Thalomid and eight inquiries about Pomalyst, two of Celgene's cancer drugs that generated more than $1.7 billion in combined sales in 2017.
Celgene spokesman Brian Gill said in an email that the company "supports the FDA's efforts to promote ongoing innovation and patient safety while ensuring generic competition," and that Celgene has sold and will sell their products to generic manufacturers "subject reasonable safety-related and business requirements."
The FDA also posted 21 safety determination letters to branded drug companies that said that there was no reason why generic manufacturers couldn't obtain branded drug samples. Actelion received eight letters since 2013 about its pulmonary hypertension medications. Celgene received four letters regarding Revlimid, as well as another two for Thalomid.
The move is the latest Trump administration action to address high drug prices. Earlier this month, Gottlieb proposed making changes to drug rebate laws to reduce prices.
In a statement, Chip Davis, president and CEO of the Association for Accessible Medicines, called the FDA's move an important step forward toward ending the "shenanigans" of branded drug makers to stifle generic competition.
"Publicly listing the bad actors who have, for years, denied access to samples reveals which companies are putting profits ahead of patients," Davis said.
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