While any DTC drug commercial will likely include shots of people happily hiking and a list of side effects longer than the symptoms of the disease it’s curing, one thing you won’t see advertised is the price of the prescription. New federal policy could change that for drugs covered under Medicare and Medicaid, forcing companies to disclose list prices in TV advertisements. While most patients don’t typically pay the full price for their prescriptions, Health and Human Services Secretary Alex Azar says, “They deserve to know if the drug company has pushed their prices to abusive levels.” PhRMA says their members would be willing to include a link to a website that has pricing information in advertisements, to which Azar pretty much replied, that’s not what I meant.
American Patients First. Catchy title. Unless you’ve been under a rock, you’ve likely heard of President Trump’s “sweeping” drug pricing proposals. While it’s way too complicated a topic to cover in our typical article length, we’re going to provide some of the better summaries. First is a nice summary about how this could impact the drug distribution system. Second is about how PhRMA increased its lobbying by 30% in 2017. Third is how Wall St. reacted in a positive manner on Friday, signaling Wall St. isn’t scared of the Trump plan for drug makers. Our last point is how Health & Human Services (HHS) Secretary Alex Azar said pharmacy benefit managers (PBMs) are a prime target in the effort. There will be lots more to digest in the future as the plan is unraveled. As the Brits say, keep calm and carry on.
The good news for pharma companies is that according to a recent report from PhRMA, 74% of medicines in clinical development are potentially first-in-class medicines. Some other findings: 822 projects—defined as unique molecule-indication combinations—are designated by the U.S. FDA as orphan drugs; 529 projects are using cell therapy; 202 projects are using gene therapy; and 173 are using DNA or RNA therapeutics. Recently, we’ve all had our fill of drug pricing commentary, and if the 74% holds true through approval, it will put the biopharma industry in a strong position to defend pricing strategies. While there are silver medals in some competitions, coming in second in the drug development race can be catastrophic. Maybe Ricky Bobby was right.
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The FDA announced an amendment regarding citizen petitions that will impact branded drug makers. A citizen petition is supposed to be submitted to the FDA if the safety or efficacy of a drug is in question. The drug is then delayed or blocked from going to market. Some companies have instead used this process as a tactic to protect sales of their drug against would-be competing biosimilars and generics. But effective January 9, 2017, a citizen petition will not be considered if the drug in question “[does] not raise valid scientific and/or legal issues.” Industry lobby group PhRMA has issued requests regarding the amendment, most of which the FDA has rejected. You can bet the battle is far from over with companies’ patents in play.
Teva wants in the club. PhRMA, to be exact. Some existing members of PhRMA want the world’s largest generics company to take a long walk off a short pier. Probably something to do with the long, ugly history of patent challenges. AbbVie EVP, Carlos Alban, for one, wrote Teva’s membership would dilute PhRMA’s emphasis on innovation. Teva touts its more than $6 Billion in branded revenue as evidence to the contrary. And here’s another problem for those throwing shade on Teva’s application… PhRMA’s membership already includes companies with substantial interests in generic products (see Novartis / Sandoz, Pfizer / Hospira, and others). We think PhRMA will have a difficult time denying Teva’s application. But we also think the welcome dinner may be poorly attended.