05.18.18

FDA Publicly Lists Drugmakers It Says May Be Delaying Generics

Source: Medscape

The US Food and Drug Administration (FDA) has followed through on its promise to publicly name companies it says may be gaming drug laws to block generic competition.

 The act comes as part of the Trump administration’s recently announced effort to bring down the price of pharmaceuticals. The list—posted on the FDA’s website May 17—includes dozens of both generic and brand-name companies that the agency said appear to have refused to give up samples of their product to generic companies seeking to make copies. Without the samples, generic manufacturers can’t conduct bioequivalence testing and apply to the agency for approval, said commissioner Scott Gottlieb, MD, in a statement.

The agency has received more than 150 pleas for help from generic drugmakers who have not been able to get samples from brand companies, said Gottlieb. “We’re also notifying the Federal Trade Commission (FTC) — the agency responsible for addressing anticompetitive business practices — about these inquiries,” he said.

According to the list, the largest numbers of inquiries have been for problems getting copies of isotretinoin (14 inquiries), bosentan (14), lenalidomide (13), thalidomide (10), and ambrisentan (10).

Among the companies that appear to be multiple offenders:

  • Actelion Pharmaceuticals, listed for potentially blocking access to macitentan (Opsumit), bosentan (Tracleer), epoprostenol sodium (Veletri), and miglustat (Zavesca);
  • Celgene, for lenalidomide (Revlimid), thalidomide (Thalomid), and pomalidomide (Pomalyst); and
  • Novartis, for everolimus (Afinitor), deferasirox (Exjade), nilotinib hydrochloride monohydrate (Tasigna), and everolimus (Zortress).

Celgene, in a statement emailed to Medscape Medical News, said it had “sold and will sell our groundbreaking products to generic manufacturers for the purposes of bioequivalence testing, subject to reasonable safety-related and business requirements” and noted that generic versions of its drugs, including Revlimid, have been licensed for sale and will enter the market in coming years. In addition, manufacturers have filed numerous applications for generic versions of its products, said the company.

“Celgene supports federal legislative and regulatory action that provides for innovators to sell samples to prospective generic applicants on commercially reasonable terms while ensuring appropriate safety and liability protections,” said the company.

Novartis, meanwhile, said it “disagrees with the inclusion of our products on the list.” In a statement to Medscape Medical News, a company spokesperson said, “It’s important to note the FDA has not independently investigated or confirmed the access limitations. To our knowledge, there are no restrictions preventing generic manufacturers from accessing these Novartis products and we have communicated that to generics companies that have contacted Novartis with similar requests.”

Some companies known as being primarily generic manufacturers were also on the list, including Ranbaxy/Sun, Mylan Pharmaceuticals, and Teva Pharmaceuticals.

The FDA said it has heard about many different ways that brand-name manufacturers have blocked access to samples, including making it hard for generic companies to purchase them at a fair value and in the open marketplace, or by putting restrictions in contracts with distributors, wholesalers, or specialty pharmacies that limit those middlemen’s ability to sell samples to generic drug developers.

 Generic makers need 1500 to 5000 units of a medication to conduct proper bioequivalence testing, said Gottlieb.

Another oft-used tactic, according to the FDA,  is claiming that samples can’t be provided when the brand name is subject to a risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU). But Gottlieb said, “Many of the products that we have received inquiries about are not subject to REMS with ETASU.”

According to the generic drug industry lobbying arm—the Association for Accessible Medicines (AAM)—27 products on the list had no REMS with ETASU.

Even in cases where a REMS with ETASU program exists, “generic drug developers should be able to secure samples of the product,” said Gottlieb.

PhRMA, the industry association for brand name drug makers, said the agency was jumping the gun on releasing company names. PhRMA is “concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said the organization, in a statement emailed to Medscape Medical News.

“Additional context is essential,” said PhRMA. For instance, the FDA should disclose that it may have already determined that a brand-name company would not be in violation of its REMS with ETASU limitations if it provided samples to a generic company.  The agency should also give companies the ability to show how they responded to the sample requests after that FDA determination.

But the generic industry applauded the FDA’s action. “Publicly listing the bad actors who have, for years, denied access to samples reveals which companies are putting profits ahead of patients,” said AAM President and CEO Chip Davis in a comment emailed to Medscape Medical News.

The FDA says it will update this list periodically.

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