Congress Mulls Major Drug-Pricing Proposals

Changes include faster generic approvals and more-transparent PBMs

Several bills aimed at controlling the high cost of prescription drugs are slowly wending their way through Congress, according to an article in The New York Times. Here’s a list of the major drug-pricing proposals currently under consideration.

  • Speeding the approval of generic drugs

A proposed bipartisan bill in the Senate seeks to streamline the approval process for generic drugs by requiring, for example, that the FDA set a deadline of eight months in which to approve new generic treatments that have little competition, according to the Times.

Meanwhile, the Senate Health, Education, Labor, and Pensions Committee voted this month to include a proposal in a bill that would reauthorize the pharma industry user-fee program, which funds much of the drug-approval process at the FDA.

In the House, a proposal would require the FDA to work more closely with companies that want to make generic alternatives to drugs for which there is little competition. The bill would also give those manufacturers a six-month window during which no other generic drug-maker could compete. This month, the health subcommittee of the House Energy and Commerce Committee voted to include the measure in its version of the user-fee bill.

Dr. Scott Gottlieb, the newly confirmed commissioner of the FDA, has said he is considering changes that would speed up the approval of generic drugs.

  • Requiring notice when drug prices rise

A bipartisan bill introduced by Senator John McCain (R-Arizona) and others would require that drug companies give notice and provide justification whenever their prices go up by a certain amount. The brand-name pharma industry opposes the idea.

  • Importing drugs from outside the United States

Some members of Congress have proposed allowing Americans to import cheaper drugs from other countries. The pharma industry has said, however, that such measures could lead to the importing of unsafe drugs, and the four most-recent commissioners of the FDA have also opposed the bills.

  • Requiring PBMs to be more transparent

Legislation introduced in the Senate would require pharmacy benefit managers (PBMs) to disclose the amount of rebates they negotiate with drug-makers for Medicare drug plans, among other measures. Another bill, sponsored in the House and supported by independent pharmacy groups, would also push for more transparency.

The trade group for PBMs has opposed both measures, saying PBMs’ secret negotiations are what permit them to get better deals. Brand-name pharma companies also oppose both bills.

  • Allowing the federal government to negotiate the price of drugs covered by Medicare

President Donald Trump has repeatedly wondered why the U.S. isn’t allowed to negotiate the prices that it pays for Medicare. But allowing the federal government to negotiate prices for Medicare’s prescription drug program (Part D) has traditionally been opposed by the pharma industry as well as by Republicans.

Now, Democratic lawmakers are essentially calling Trump’s bluff, according to the Times. Will he buck Republican orthodoxy and back a Democratic idea?

Recently, Mick Mulvaney, the director of the Office of Management and Budget, said one option under consideration was to impose mandatory rebates on drugs purchased by Medicare, similar to the ones required by Medicaid.

Source: The New York Times; May 29, 2017.