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The FDA is taking steps to increase the number of generic drugs on the market as part of its overall plan to increase competition and lower drug prices.
The Food and Drug Administration June 27 said it is implementing a new policy to expedite the review of generic drug applications until a given drug product has three approved generics.
The agency also published a list of off-patent, off-exclusivity branded drugs that lack generic competition, which is intended to spur manufacturers to develop generic versions of these drugs. These actions are part of the agency’s Drug Competition Action Plan, announced by FDA Commissioner Scott Gottlieb June 21. The more generic drug competition a particular drug has, the lower its price.
The FDA’s actions come as drugmakers are under heavy scrutiny by lawmakers, consumers, medical professionals, and the president for their pricing practices. The increased focus on drug prices was spurred by companies significantly hiking the prices of older pharmaceutical products that lacked competition.
“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” Gottlieb said in a statement. “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work, and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”
The FDA also recently announced it will hold a public meeting on July 18 to solicit input on places where the FDA’s rules are being used in ways that may create obstacles to generic access.
The FDA’s list of off-patent, off-exclusivity drugs includes Pyrimethamine, which is sold under the brand name Daraprim. Martin Shkreli, the former chief executive officer of Turing Pharmaceuticals AG, purchased Daraprim in 2015 and increased the price from $13.50 to $750 per tablet. Daraprim is used to treat toxoplasmosis, a parasitic infection that can be life-threatening for people with HIV/AIDS, cancer, and other conditions that cause compromised immune systems.
Also on the FDA’s list of off-patent drugs is the HIV drug enfuvirtide. Genentech Inc., a member of the Roche Group, markets enfuvirtide under the brand name Fuzeon. Another drug on the list, clofazimine, treats leprosy. Clofazimine is sold under the brand name Lamprene by Novartis.
On June 26, in a separate action, the FDA also posted a list of drugs where the agency has recently received a generic application with a Paragraph IV patent certification.
Paragraph IV certifications are filed by generic drug manufacturers to certify that their proposed products won’t infringe a brand-name maker’s patent and/or challenge the patent as invalid. The first applicant to file a generic drug application containing a Paragraph IV certification receives 180 days of market exclusivity.
Included on that list is Teva Pharmaceutical Industries Ltd.'s Bendeka (bendamustine HCL injection), which is used to treat certain types of cancer. Also on the list is Insys Therapeutics Inc.'s Syndros (dronabinol oral solution), which treats anorexia associated with AIDS and nausea and vomiting associated with cancer chemotherapy; and Gilead Sciences Inc.'s Truvada (emtricitabine and tenofovir disoproxil fumarate tablets), which treats HIV infection.
The Association for Accessible Medicines (AAM), formerly the Generic Pharmaceutical Association, applauded the FDA’s actions to increase generic competition.
Gottlieb’s “swift and decisive action to expand access to safe, effective, and affordable generic and biosimilar medicines is of tremendous benefit for our nation’s patients,” said Chip Davis, president and chief executive officer of AAM, said in a June 27 statement. The FDA’s announcement “signals that any serious effort by the Trump Administration or the United States Congress to bring down drug costs for patients must include more affordable generics and biosimilars. AAM looks forward to working with FDA and policymakers on all possible ways to further enhance competition and improve the first cycle approval rate for generic drug applications.”
Premier Inc. said in a June 28 statement that while it supports the FDA’s actions, more needs to be done. Premier is a health-care improvement company, uniting an alliance of approximately 3,750 U.S. hospitals and more than 130,000 other provider organizations.
“Hospitals, caregivers and consumers have experienced significant price spikes and shortages in generic drugs when there is a lack of competition in the market,” Premier said. The FDA’s action to expedite the review of generic drug applications “will help address this problem.”
Premier also said it applauds the FDA’s publication of the off-patent, off-exclusivity branded drug list. “After reviewing the list, Premier has already identified a number of critical drugs for patient care and already begun outreach to manufacturers to participate in the FDA’s new expedited process,” the alliance said.
“While we applaud these important actions by the FDA to address issues that are helping to cause high drug prices and shortages, we recognize that more needs to be done. Premier recently released nine policy recommendations Congress and the administration should take to create healthier and more competitive pharmaceutical markets, and drive toward the goal of achieving a high-quality, cost-effective pharmaceutical industry,” Premier said.
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