The Department of Health and Human Services has directed the FDA to consider the importation of foreign drugs to address price spikes. The proposed policy would only apply to drugs unaffected by patent or exclusivity, in an effort to avoid intellectual property issues. However, pharma companies may still have something to say through their lawyers if such a policy were to be implemented, especially as an act of a federal agency instead of legislation. If it were implemented though, it would avoid patient access issues in situations like when an HIV medication jumped in price from $13.50 to $750, which had the incredibly unfortunate side effect of catapulting Martin Shkreli’s infinitely punchable face into the limelight. That drug still costs $750 by the way. Or just 5-10 cents in India.
Which better describes how you feel about Allergan’s transfer of the Restasis patent to the Native American tribe?
“Your patent has expired” might be the four most dreaded words a pharma company CEO can hear. A close runner-up: “SEC on line two.” But, like death and taxes, patent exclusivity is a certainty and in 2018 at least 26 prominent drugs will lose their protection. According to EvaluatePharma this could cost drug makers $31 billion in 2018 alone. The biggest loser: Pfizer’s Lyrica (pregabalin) for fibromyalgia and neuropathic pain, which had 2016 sales of $5 billion. Might be a good time to be a generic company, but don’t ask Teva, as Scott Gottlieb tweeted about how active the FDA has been in approving generic products. Several market research reports put the worldwide value of the generics market around $200 billion. And with decisions like this being made, the sky is the limit.
Hepatitis C is expensive to treat, which is why a lot of patients don’t get treated for it, and that possibly contributes to why it’s the deadliest infectious disease in the US. It’s gotten to the point where states are considering legal challenges to those precious patent laws that pharma typically spends a lot of money on to make sure no one touches. So, in the fight to increase Hep C treatment, in one corner we have legal challenges, and in the other we have good ol’ market forces. Abbvie’s new Mavyret costs well less than half the amount of some existing treatments, and it can treat all six strains of the infection. Your move competition, may the markets be ever in your favor.
Transparency and drug discovery don’t usually go together, what with patents, IP and paywalls hiding useful knowledge from researchers working on similar problems. But the Structural Genomics Consortium has a different approach. That’s right, crowdsourcing has made its way to drug discovery. The SGC partners with six research universities, nine of the largest pharma innovators, and government agencies to provide open source data about protein structures that can be used to develop hard-to-design drugs. They’re currently using the approach to, ahem, stick it to Huntington’s (see, it’s funny because they’re literally trying to bind molecules to the protein that causes the disease.) For a small contribution of $8 million—cheap by R&D standards—any organization can nominate proteins to the SGC’s master to-do list.