Manatt Health National Advisor Ian Spatz was quoted in Law360 on the U.S. Department of Health and Human Services’ (HHS) recently released list of drugs chosen for the first round of Medicare price negotiations, commenting on the Department’s criteria for selecting negotiation-eligible products as companies continue to challenge the drug pricing program.
In the article, Spatz explained that there are questions surrounding how HHS selects eligible drugs, noting that there is a lack of “specific, measurable and auditable criteria for when there will be sufficient competition” from lower-cost generics, thus creating uncertainty regarding exemptions for brand-name drugs. He added that although HHS said it would scrutinize whether "bona fide competition" exists from lower-cost generics, it may be difficult to know whether the competition will be deemed sufficient without the creation of more clear guidelines.
Read the full Law360 article here.