Policy

An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.
The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.
Among the features of the Part D structure is a federal reinsurance program in which, when a beneficiary reaches the catastrophic threshold in a given year, the government subsidizes 80% of remaining spending for the year. Part D plans pay 15%, and patients pay 5% in this scenario.
A federal appeals court Wednesday struck down the individual mandate—the heart of the Affordable Care Act (ACA) that requires everyone to have health coverage—and sent the case back to the federal district court in Texas to determine whether other parts of the law are constitutional and can exist without the mandate.
Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price—but different NDCs will not be available for use by biosimilar manufacturers.
 
Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.
On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA.
Alberta became the most recent Canadian provincial government to mandate a nonmedical switch to biosimilars for certain patients on taxpayer-funded drug plans.
An agreement on the United States–Mexico–Canada Agreement (USMCA), a trade deal that updates the North American Free Trade Agreement, has been reached, and proponents of biosimilars and generics have cause to celebrate after the removal of provisions that some said would hinder competition.
Trade representatives for Canada and Mexico met last week over the ratification and implementation of the United States–Mexico–Canada Agreement (USMCA), and press reports say that the Trump administration is considering acceding to Democrats’ demands to reduce patent protections for reference biologics in order to get the pact through Congress.

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