A bill that includes a provision co-authored by U.S. Sen. Susan Collins to lower drug prices awaits President Donald Trump’s signature.
The provision, part of the Food and Drug Administration’s Reauthorization Act, seeks to keep prescription drug prices down by speeding up timelines and inspection procedures for the FDA’s review of applications for generic drug production. Among other measures, it gives the FDA latitude to speed up inspections and approvals of medication manufacturing facilities and calls on the agency to provide more status updates about generic drugs that already are in the process after their name-brand counterparts have had their patents and exclusivity clauses expire.
Collins, who authored the provision in partnership with Sen. Claire McCaskill, D-Missouri, said in a news release that the legislation resulted from an investigation launched in 2015 into egregious price spikes for prescription drugs. She said it will help prevent gigantic increases in prescription drug prices.
“Our legislation will help to foster a much healthier and more competitive marketplace as the best defense against such exploitation,” Collins said in a news release.
The report by the Senate Aging Committee, which Collins chairs, studied abrupt price increases for medications whose patents have already expired. It found that some companies have exploited market failures by acquiring decades-old, off-patent and previously affordable drugs and then raised prices at the expense of patients. When the report was released, Collins called the practice the “hedge fund” model of medication production and marketing.
The report also called for targeted generic drug importation, crackdowns on the misuse of patients assistance and coupon programs and more authority for the Federal Trade Commission to oversee drug company mergers. The report focused on four companies, including Turing Pharmaceuticals, which made international headlines when it raised the cost of an antiparasitic drug called Daraprim by 5,000 percent. Turing CEO Martin Shkreli then bragged publicly about the deal and said he would do it again if he could find another medication to do it with.
Shkreli became the target of international ire and on Friday was convicted of a series of securities fraud charges and faces up to 20 years in prison.
The amendment by Collins and McCaskill is part of a much larger bill which, among other things, allows the FDA to accept user fees from manufacturers of drugs and medical devices for the next five years. Revenue from the fees will be used for product development, transparency measures and research. The bill received an unanimous recommendation from the Senate Committee on Health, Education, Labor and Pensions Committee, of which Collins is a member.
Collins said the bill will benefit senior citizens, who she said “take a disproportionate number of the prescription drugs that are prescribed in this country.”
A similar version of the Collins-McCaskill amendment passed in the U.S. House last month and now sits on Trump’s desk. Presumably, it’s on his desk at a golf course in New Jersey, where the president is taking a working vacation during renovations at the White House.
This item was originally published in Daily Brief, a free political newsletter distributed Monday through Friday by the Bangor Daily News to inform dialogue about Maine politics and government. To read more of today’s Daily Brief, click here. To have the Daily Brief delivered daily to your inbox, click here.
