House Judiciary Committee Advances Four Bills Targeted at Generic Competition
Setting up a House floor vote which could come in the next several weeks, the House Judiciary Committee on Tuesday advanced four bills, including the CREATES Act, that would aim to better ensure generic drug competition.While the bills are not likely to bring down the cost of prescription medicines in the near term, they will likely help to level the playing field for generic drug companies.
For instance, the bipartisan HR 965, known as the CREATES Act, previously advanced through the House Energy & Commerce Committee and is projected to save $3.9 billion for the federal government by enabling generic and biosimilar developers to obtain the necessary samples of a reference drug or biologic to show bioequivalence, biosimilarity or interchangeability.
The bill comes as the US Food and Drug Administration (FDA) has received numerous inquiries from prospective generic applicants indicating that they would like to develop a generic version of a marketed drug, but are unable to obtain the necessary samples of the reference listed drug.
Similarly, HR 2375, the “Preserve Access to Affordable Generics and Biosimilars Act” is meant to halt anticompetitive agreements between generic and brand name manufacturers. Most recently, the Federal Trade Commission (FTC) found that even an agreement not to market an authorized generic can be considered a form of reverse payment to delay the entry of generic competition.
HR 2374, the ‘‘Stop STALLING Act,” also advanced and would seek to stop the submissions of sham citizen petitions to the US Food and Drug Administration, as they currently can stall the marketing of generic drugs. Last October, FDA issued revised draft guidance to try to stem the tide of citizen petitions that are just meant to delay the approval of new generic drugs.
Finally, the House Judiciary Committee advanced by voice vote HR 2376, the “Prescription Pricing for People Act of 2019,” which would enlist the Federal Trade Commission to study and report on pharmacy benefit managers and whether they steer patients to certain pharmacies for anticompetitive purposes, among other provisions.
House Judiciary Markup