FDA identifies companies ‘potentially blocking access’ to drug samples
The US Food and Drug Administration (FDA) has published a list of companies that it suspects might be preventing generic drug producers accessing samples of branded products.
FDA commissioner Scott Gottlieb issued a statement on Thursday, May 17, revealing the agency’s new efforts to clamp down on branded drug producers “pursuing gaming tactics” to delay generic competition.
Gottlieb said the FDA has received more than 150 enquiries from generic companies seeking assistance with obtaining drug samples to perform “relatively straightforward” studies for FDA approval.
The drug that has received the most enquiries (14) is Tracleer (bosentan), which is made by Actelion Pharmaceuticals to treat pulmonary artery hypertension. Next on the list is cancer drug Revlimid (lenalidomide), produced by Celgene, which has received 13 enquiries.
Other major drugs companies and products are on the list, which you can find here.
The FDA added that some drugs are associated with a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU), which affects drug distribution.
REMS is a drug safety programme that the FDA can require for certain medications for which there are serious safety concerns, “to help ensure the benefits of the medication outweigh its risks”.
Providing more detail on REMS, Gottlieb said: “We have heard that some drug makers have either refused to sell samples of products with REMS with ETASU … or have imposed conditions on the sale of such samples that generic companies find hard or impossible to comply with.
“In other cases, we understand that brand companies have placed restrictions in their commercial contracts or agreements with prescription drug distributors, wholesalers or speciality pharmacies that limit the ability of these intermediaries in the drug supply chain to sell samples to generic drug developers for testing,” he added.
But despite this, Gottlieb said: “A path to securing samples of brand drugs for the purpose of generic drug development should always be available.”
After the FDA receives enquires from generic companies, first it will determine whether the products have a REMS programme with ETASU in place, “which has been cited as a reason to refuse to provide samples”, Gottlieb said.
“In many cases, we find that there’s no such REMS programme in place. In these cases, the FDA informs the generic drug developer that there are no FDA-required restrictions on the distribution of the drug that would impede obtaining samples,” he added.
Even where an appropriate REMS is in place, the FDA is offering to help speed up the transfer of samples by allowing generic companies to submit their bioequivalence testing protocols to the agency, “and we will evaluate these protocols to ensure that their plan for testing the product contains safety protections comparable to the brand product’s REMS programme”.
“Assuming that the generic drug developers’ plans include appropriate protections, then the generic drug developers can request the FDA to send a letter to the brand company stating that the REMS programme does not mean the brand drug maker can’t sell its product to generic drug developers for comparative testing,” Gottlieb said.
These notifications are called Safety Determination Letters, he explained, and the FDA has issued 21 of these to date.
According to the list, Tracleer and Revlimid have both been subject to such safety letters.
The FDA will continue to update the list of companies periodically, Gottlieb concluded.
A spokesperson for Celgene said the company supports the FDA’s efforts to promote ongoing innovation and patient safety while ensuring generic competition.
"We have sold and will sell our groundbreaking products to generic manufacturers for the purposes of bioequivalence testing, subject to reasonable safety-related and business requirements.
"There are generic versions for a number of our drugs, including Revlimid, licensed to enter the market in coming years, and manufacturers have filed numerous ANDAs for generic versions of our medicines.”
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