FDA Publicly Lists Drugmakers It Says May Be Delaying Generics

Authored by medscape.com and submitted by Brad_Wesley
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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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datareinidearaus on May 18th, 2018 at 01:58 UTC »

The first generic to challenge a patent, gets 6 months of exclusivity, with the brand name. A duopoly. After that, all other generics can come in, after showing bioequivalence. (They get around this by paying generics to stay away)

3 main ways companies block generics...

1) Pay for delay. Effective Bribe. Brand name pays first filing generic not to come into market. Settling Hatch-Waxman. However, 6 month Duopoly period does not start until first generic actually comes to market. So this can be stretched out continuously. Congress has attempted to fix this numerous times by changing wording, but companies just keep getting nimbler with the law. Price stays higher for a longer period of time, bad for consumers. Supreme court ruled in 2013 that this could be challenged as anti-trust. So companies moved away from the simple versions of this. 2) Similar to #1, but more complex. Payments are more difficult to detect. But generic still stays off market. Maybe the Brand pays generic to do something economically idiotic, like market the drug. Or to do anything really, where the generic is a useless middleman. Ways which are much harder to detect and enforce as anti-trust. (Like paying a college athlete 10k a month to work part time in an office) Still active. 3) #1 and #2 about collusion. This is about obstruction. Blocking the generics out completely. Evergreening and product hopping; minor modification to delivery or dosing get a new patent and to keep generic from enacting. Asacol; company tried to product hop. Failed. So they stuck a new patent on old capsule, by sticking a new ineffective capsule around it. Literally just took the old capsule, and stuck it inside a new one; you could cut the new capsule and the old one would fall out. But they got a new patent for it. AND, they removed all of the old drug off the market. No more equivalency. Citizen petition; asking the FDA to not approve a generic. Started in 70s as power to ordinary citizens. Doubled since 2003. Ask the FDA to do things the already do, or are impossible. FDA denies 80% of time, but it still takes time. 1/5 petitions were related to delaying generic from market. 40% were filed with/in year of patent cliff. FDA has 5 months to respond. This could be 100s of millions of sales.

We need to change this shit

HamburgerDude on May 17th, 2018 at 21:24 UTC »

If pregabalin doesn’t go generic at the end of this year because of the bill I’m going to flip. It works far better for my pain than gabapentin but it’s far more expensive.

LudovicoSpecs on May 17th, 2018 at 20:45 UTC »

Novartis is on the list.