Generic drug companies actively trying to get their products on shelves want senators to update language in a sweeping health-care bill meant to dissuade companies from squatting on patents to block competition.
The BLOCKING Act would strip generic drugmakers of exclusivity rights if they fail to get their generic drug approved under certain circumstances, like within 30 months of first submitting an application to develop the generic, among other things. The measure is included as part of the broader Lower Health Care Costs Act (S.1895).
The proposal is meant to address the issue of “parking,” when a generic company sits on its right to produce a drug without actually getting it approved. That essentially blocks that generic from coming to the market because another company can’t begin to produce its own generic until the first filer’s exclusivity right is up.
Generic drugmakers sometimes “park” their applications “in situations where they reach business agreements with brand sponsors not to launch a generic competitor,” Scott Gottlieb, the former FDA commissioner, wrote in an American Enterprise Institute blog in May. “These arrangements, while decreasing in frequency, allow the branded drug maker and the first generic applicant to extend the effective patent life of the branded drug, and then divide the resulting monopoly revenues, which can be substantial.”
Drugmakers, including Teva Pharmaceutical Industries, and the Association for Accessible Medicines said drug companies actively trying to get their medications through the approval process shouldn’t be punished if they hit a snag that takes them beyond the 180-day exclusivity period. They are arguing for a tweak in the bill’s language that would allow the exclusivity period to continue as long as the generic drugmaker is actively working to get the product to market. That’s a tweak Gottlieb supports, according to his May blog post for AEI.
“A company that’s playing by the rules can lose its exclusivity through no fault of its own,” Jeff Francer, general counsel for the Association for Accessible Medicines, a generic drug trade group, said.
The health-care package will be debated in the Senate Health, Education, Labor, and Pensions committee on June 26, but generic drugmakers think they have bipartisan support for tweaking the language around generic drug exclusivity periods.
The exclusivity window is a major incentive for the generic industry, and if it’s watered down it will lead to fewer patent challenges, fewer generics, drug shortages, and less savings for consumers, Brian McCormick, the chief regulatory counsel for Teva, told reporters June 24.
“You’d think generic and biosimilar companies would be overjoyed by that package,” Francer said.
Negative consequences of the bill—like taking away incentives to challenge brand drug patents—will force the association to oppose it if the language remains unchanged, he said.
“The BLOCKING Act will do so much damage to incentives to challenge brand patents that negative repercussions will take us significantly backward in terms of drug pricing issues and drug patent issues” that lawmakers are trying to address, Francer said.