Republican and Democratic leaders of the House and Senate judiciary committees have introduced legislation designed to speed the development of generic drugs. Targeting what Sen. Patrick Leahy (D-Vt.) called “abusive delay tactics,” the legislation would create a private right of action allowing generic manufacturers to sue innovators to gain access to brand-name drugs protected by FDA safety programs. Including the private party lawsuit in the legislation allows the bill to be referred to the judiciary committees, which can hold hearings and vote to approve the bill. A Senate judiciary subcommittee last year held a hearing on similar legislation.
The legislation was introduced by Leahy and Sen. Chuck Grassley (R-Iowa), and Reps. Tom Marino (R-Pa.) and David Cicilline (D-R.I.). Grassley is chairman of the Senate Judiciary Committee, and Marino is chairman of the House Judiciary Subcommittee on Antitrust Law. It has also been reported that Marino will be tapped by President Trump to head the Office of National Drug Control Policy.
Brand-name manufacturers oppose the new legislation, saying it would ignore FDA-imposed safety requirements on high-risk drugs and cause unnecessary litigation. The bill follows similar legislation introduced in the House last month that would compel brand-name companies to make their products available to generic drug makers for bioequivalence testing, but that bill doesn’t include a private right of action against the brand-name drug companies.
Both bills have been introduced in previous sessions of Congress and failed to gain significant traction. But both have picked up new bipartisan support as the issue of drug prices continues to swirl on Capitol Hill.