A Senate panel advanced key legislation that would prevent brand name drug companies from blocking access to much cheaper generic drugs.
The Senate Judiciary Committee voted 16-5 on Thursday to advance the CREATES Act to the Senate floor. The bill would make it easier for generic drug makers to sue brand name drug makers that prevent access to samples of a product of which they want to make a cheaper generic version.
“It targets a simple yet devastating scheme that some brand name drug companies have used to keep drug prices high,” said Sen. Patrick Leahy, D-Vt., one of the bill’s sponsors.
A generic company needs up to 5,000 samples of a brand name drug ito conduct required tests for Food and Drug Administration approval.
However, brand name drug companies sometimes employ strategies to block generic companies from getting samples.
Those strategies include making an agreement with a specialty pharmacy to not sell samples to generic companies. Another approach employs using an FDA safety strategy to restrict access.
The FDA sometimes enters into a joint agreement with a brand name drugmaker for a new product to restrict distribution. A brand name drug maker has cited that strategy when a generic maker comes calling for samples.
Generic drug companies already can sue brand name companies if they block access to samples. The CREATES Act, officially the “Creating and Restoring Equal Access to Equivalent Samples Act of 2017, ” would make it easier and faster for generic companies to get relief from the courts if a brand name company blocks them.
Senators have expressed concerns about the bill. Sen. John Cornyn, R-Texas, wanted to offer an amendment that would give an injunction to the brand name drug company instead of granting damages to the generic drug company. He withdrew the amendment after receiving an agreement from Senate Judiciary Chairman Chuck Grassley, R-Iowa, to work further on the bill.
Republican Sens. Jeff Flake of Arizona, Mike Crapo of Idaho, Orrin Hatch of Utah, Ben Sasse of Nebraska and Thom Tillis of North Carolina opposed the bill.
