- PhRMA President Stephen Ubl called on the Food and Drug Administration to improve its review process for new combination products such as Mylan's EpiPen, penning a blog post published Tuesday which proposed a number of ideas to "increase epinephrine auto-injector competition."
- Mylan has sharply increased the price of the EpiPen since acquiring the anaphylaxis treatment in 2007, stirring up renewed furor over the rising cost of prescription drugs.
- PhRMA, as the main trade association of the pharmaceutical industry, has sought to highlight the cost of R&D for new products and the price of innovation in response to the widespread criticism of the industry.
Mylan has been attacked for its aggressive pricing of EpiPen, prompting the drugmaker to offer a $300 rebate for some patients, expand patient access programs and unveil plans to launch an authorized generic copy of EpiPen for half the cost.
Some, including Democratic presidential nominee Hillary Clinton, have seen Mylan as the latest example of pharmaceutical price-gouging, following the footsteps of Turing Pharmaceuticals and Valeant.
In Tuesday's blog post, PhRMA's Ubl highlighted the lack of competition for EpiPen and put the onus on the FDA to ramp up its support for development of new combination products. (Epipen combines epinephrine with a auto-injector delivery device.)
"We need the U.S. Food and Drug Administration to bolster support for the development of new combination products, such as epinephrine auto-injectors, by improving the review process and continuing its efforts to address the backlog of new generic drug applications," Ubl wrote.
Mylan has a de facto monopoly in the U.S. after Sanofi's withdrawal of competing Auvi-Q from the market. The FDA has so far found applications for approval of other epinephrine products from generic companies, including Teva, to be insufficient.
Ubl's post, which did not mention Mylan by name or acknowledge rising prices for EpiPen, also highlighted what PhRMA deems to be inefficiencies in the current regulatory system. Ubl pointed to the challenges faced by biopharmaceutical companies developing combination products, including differing regulatory frameworks governing approval of medicines, devices and biologics.
Ubl proposed further exploration of alternative financial incentives to boost generic entry, such as a targeted grant program for manufacturing investments in generic products.
PhRMA has traditionally been an association made of branded pharmaceutical companies but recently opened the door to generic drugmakers with the inclusion of Teva in its membership last month.