With the drumbeat growing ever louder for curbs on U.S. drug prices and President-elect Donald Trump pledging during his campaign to take action, analysts are expecting some of the legislative and regulatory proposals in a new Senate report to take flight in 2017.
Those changes focus on giving companies incentives to develop rivals to so-called sole-source drugs — medicines that have no FDA-approved equivalents available — and not on reining in the prices of products from large brand-name manufacturers.
Much of what was included in the Dec. 21 report from the Senate Special Committee on Aging had been hashed out over the past year in a series of Capitol Hill hearings and elsewhere.
Even the legislative and regulatory proposals outlined in the report previously had been recommended by the committee's leaders or others in Congress and only target a certain segment of the pharmaceutical industry.
What the committee did not do in its report, however, is take aim at the price increases by so-called "big pharma" companies, such as Novartis AG, whose leukemia medicine Gleevec now costs about $120,000 per year, versus about $26,000 in 2001, and Biogen Inc., which has raised the price of its multiple sclerosis drug, Avonex, by an average of 16% per year over the last decade.
Sen. Elizabeth Warren, D-Mass., who cited those figures at a March 17 hearing, had urged the committee leaders to go after all biopharmaceutical companies that had consistently raised their prices beyond 10% per year.
But Sens. Susan Collins, R-Maine, the committee's chairwoman, and ranking member Claire McCaskill, D-Mo., instead remained focused on companies whose business models they said were centered on buying up older sole-source drugs and then significantly raising their prices.
They looked at four companies — Turing Pharmaceuticals LLC, Retrophin Inc., Valeant Pharmaceuticals International Inc. and Rodelis Therapeutics Inc. Those companies end up enjoying a "de facto monopoly," because "there is no market force to prevent the manufacturer from charging whatever it wishes for the drug," the senators said.
Collins and McCaskill pointed to a number of proposals that could be reconsidered in the next Congress, including their bill, the Increasing Competition in Pharmaceuticals Act. That legislation would require the FDA to fast-track the review of applications for generic drugs for diseases in which a shortage of medicines on the market exists or only one supplier of the product and to act on those evaluations within 150 calendar days.
The bill would also reward companies that successfully apply for a product that competes with a sole-source drug or alleviates a medical shortage. Such companies would be granted a priority-review voucher, which could be used for other generic-drug applications, giving them a speedier evaluation.
Cowen & Co. analyst Rick Weissenstein said he anticipated some version of the Collins-McCaskill bill to be enacted in 2017.
Another bill that has a good shot of being passed was the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016," Weissenstein said in a Dec. 21 research note. That would bar brand-name drugmakers from using their FDA-required risk mitigation programs to withhold samples from potential generic competitors to thwart their efforts of getting their lower-cost products through the development and regulatory processes.
Collins and McCaskill also suggested that the FDA should permit generic manufacturers to create their own risk programs.
Weissenstein noted that the committee's report did not outline any ways to address the concerns lawmakers have about the use of patient assistance programs and copay coupons offered by biopharmaceutical companies to help low-income and uninsured patients cover the costs of their drugs.
The senators said those programs could drive doctors to prescribe higher-priced drugs, resulting in greater costs for federal healthcare programs and other payers.
Rather, the committee said the issue "warrants further study."
"We see this as an area the Aging Committee will focus on in 2017, meaning any action would be put off for at least a year," Weissenstein said.