FDA is throwing some serious shade on drugmakers of branded medications engaging in tactics that thwart competition from generics.
When a generic drug company wants to make a knock-off version of a branded medication, it must first obtain samples of the reference product that it can use to develop its own. Last week, however, Food and Drug Administration Commissioner Scott Gottlieb named dozens of companies that he accused of “gaming” the system by preventing access to their products.
The list highlighted the way restricted distribution of drugs — whether imposed by brand drugmakers themselves or under Risk Evaluation and Mitigation Strategies (REMS) designed to mitigate potential safety risks — prevent generic drug companies from obtaining needed samples. Many generic drug companies have complained to the FDA that they are unable to obtain samples in order to develop versions of drugs, but are unable to due to limited distribution arrangements, an introduction to the list read.
The list includes 52 drugs made by around three dozen companies, 25 of which have a REMS program that affects the distribution of the drug. The number of inquiries the FDA has received from generic drug companies interested in obtaining branded drug samples ranges from as few as one for several drugs to as many as 14, for Actelion Pharmaceuticals’ Tracleer, a drug used to treat pulmonary arterial hypertension that itself has a REMS program.
One company that got particular attention was Celgene Corp., for the drugs Thalomid, Revlimid and Pomalyst, all used primarily for the blood cancer multiple myeloma. Those drugs garnered 10, 13 and eight inquiries respectively. Revlimid, a cash cow for the company that racked up sales of nearly $8.2 billion last year, has attracted particular interest due to the immense wall of patents protecting the drug itself and its REMS. Dr. Reddy’s and Mylan are among generic manufacturers seeking to make their own versions.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Revlimid and Pomalyst are derived from Thalomid, itself a rebranded version of thalidomide, the drug infamous for causing birth defects when taken by expectant mothers in the mid-20th century but since repurposed for other diseases.
In a speech last week, Secretary of Health and Human Services Alex Azar referred to a drug that cost $11,500 per month in 2015 and has been raised by 20 percent. That, he said, means that under Medicare Part D, beneficiaries went from paying $575 per month to $690, despite the average Social Security check is $1,400. While he did not name the drug, Evercore ISI analyst Umer Raffat deduced he was referring to Revlimid, several news outlets noted.
Other companies that received multiple mentions on the FDA list included Johnson & Johnson division Actelion, Novartis, Gilead Sciences and GlaxoSmithKline.
The Association for Accessible Medicines, a lobbying group for the generic drug industry, praised the FDA’s move.
“Publicly listing the bad actors who have, for years, denied access to samples reveals which companies are putting profits ahead of patients,” said the group’s president, Chip Davis, in a statement.
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