Congress is under pressure to reduce drug prices, but the obstacles are legion. Current federal regulations protect drug makers from competition and restrict the government’s ability to negotiate bulk prices for large purchases from manufacturers. The nation’s drug distribution system is complex, opaque, short on data, and little understood by consumers. And the huge money at stake gives the drug industry every incentive to invest billions into blocking change.
More competition for the name brand drug makers from generic drug manufacturers would help. Generic drugs saved American consumers $227 billion in 2017 alone, by one estimate, but both federal policies and drug industry abuses in the past 20 years have blocked their development. In the U.S., laws meant to promote innovation have given drug makers an unusually long window of market exclusivity that protects their monopolies. The makers of new biologic drugs, for example medicines made from living cells – enjoy exclusive market rights for a dozen years. That’s seven years longer than the exclusivity granted conventional, small-molecule. drugs. A plan to restrict biologics patents and bring them in line with small-molecule drugs would have saved the government just under $7 billion over a decade, but it was anandoned as a result of heavy lobbying.
Lawmakers on both sides of the aisle have introduced more than 30 bills to curb drug prices in the past two years, All have died owing to intransigent opposition from Big Pharma. Ideas include bills to allow the importation of drugs from Canada, more pricing transparency,
tough price negotations, and making patent applicants demonstrate significant differences, originality, or additional benefit to qualify for secondary patents that extend the monopolies. Two sensible and rational ideas are, firstly, “single payer”, the single payer being government, which is the case in other advanced countries. Single payer is supported by more than half of all Americans. Secondly, value-based pricing, the idea being to tie drug prices directly to health care outcomes. The drug company would guarantee patients that its drugs would help them hit specific. markers, or they would get their money back.
But meanwhile pharmaceutical companies get up to all sorts of games, (aside from assisting Congressmen stay in their jobs!),such as:
– “pay-for-delay” agreements, where originators of a drug agree with generic manufacturers (for a price) not to develop a generic drug until a specified date, thus prolonging their exclusivity.
– refusing to sell their products to generic manufacturers for analysis, even when the patent has lapsed.
– refusing to participate with generic drug makers in safety protocols required by the FDA, citing a danger to consumers, but effectively choking off their generic rivals.
I have a chronic sleep problem. Through a sleep doctor I signed up with a company that sells drug called Xyrem, in the hope of finding something that works for more than a month at a time. In the course of organising this I asked the price. $4,750 a month!! Turns out Xyrem is a so-called “orphan” drug, originally designed for quite another condition, then sold on to Jazz Pharmaceuticals to treat (mainly) narcolepsy. In 2007 Xyrem sold for $2.04 per 100 milliliter dose, translating to a out $60 a month. This figureis now $4,750.In 2013 sales of Xyrem were $569 million. Need I say more?