A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.”
Titled the “Price Relief, Innovation, and Competition for Essential Drugs Act,” or the “PRICED Act,” the proposed bill (H.R. 5573, sponsored by Democrat Illinois Representative Janice Schakowsky) would change the exclusivity period from 12 years to 7 years for all new biologics licensed after the date of enactment of the Act.
As we’ve previously reported, the 12-year exclusivity period for biologics under the BPCIA has come under fire before: in TPP negotiations, some countries have pushed for a shorter exclusivity period under the deal (some negotiating TPP countries provide much shorter exclusivity periods, e.g. 5 years in Australia), which US negotiators have so far resisted. And although it has not yet taken concrete actions to change the BPCIA exclusivity provisions, the Obama administration has repeatedly proposed (e.g. in its annual budget plans) to reduce the 12-year exclusivity period to 7 years, as the PRICED Act now proposes to do.
The proposed bill also comes on the heels of the Supreme Court’s invitation to the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari–an invitation that provides the Obama administration with an opportunity to weigh in on the 180-day notice provision in the BPCIA and its implications for the effective exclusivity period for a reference biologic product.
This bill can be expected to attract more attention and generate strong views on both sides as it progresses through Congress. It has been referred to the House Committee on Energy and Commerce, and we’ll continue to monitor developments. Stay tuned for updates here on the Big Molecule Watch.