House E&C Subcommittee Advances 5 Bills Related to Generic Competition

Regulatory NewsRegulatory News | 27 March 2019 |  By 

The House Energy & Commerce Committee’s Health Subcommittee on Wednesday advanced five bills seeking to help increase generic drug competition. All five will now be considered by the full committee.

Much of the discussion and disagreement across the aisle centered on two bills: one, known as HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, which seeks to prevent brand name drug and biologic manufacturers from compensating generic and biosimilar makers to delay the entry of generic and biosimilar products, and another, known as HR 965, the CREATES Act of 2019, related to ensuring generic and biosimilar companies can gain access to samples of reference product for required testing.

The issue related to HR 1499, according to Republicans on the subcommittee, is that the bill works retroactively, back to 2013, so if enacted, the law could theoretically end up pulling generic drugs from the market if it was found that the generics came to market due to an unlawful agreement.

Rep. Fred Upton (R-MI) offered an amendment that would strike the parts of the bill related to its retroactive application, but, by a vote of 11 ayes to 19 nays, that amendment was not agreed to.

Democrats defended the bill, with sponsor Rep. Bobby Rush (D-IL) explaining that the retroactive provision is meant to ensure that the Federal Trade Commission (FTC) can take action against anti-competitive agreements between the time of the Actavis Supreme Court decision and the passage of this bill. “This provision gives FTC the discretion to make such a decision but does not mandate that they do so,” he said.

As for the CREATES Act, which has been introduced in various iterations since 2017, Republicans on the subcommittee took issue with what Rep. Greg Gianforte (R-MT) called “grossly excessive putative damages” for brand name drug companies that do not provide access to samples of their drugs so generic drugmakers can bring competitors to market.

“Putting the entire revenue of a company into play would put the company at risk of frivolous lawsuits,” he said, noting specific concerns for small companies with only one product on the market.

Rep. Peter Welch (D-VT), however, disagreed with that characterization and said if it’s one company with one drug “that’s ripping off consumers,” they’ll get “no sympathy from me. The damages are reflective of the revenue stream when there was abusive behavior.”

Rep. Frank Pallone (D-NJ) also clarified that the penalties under CREATES could be, at most, the revenue made during the period when the brand name drug company didn’t provide samples, not for the entire lifetime that the product was marketed.

Gianforte, whose amendment to change the type of penalties was defeated, also added: “We all agree on the intent of this entire bill. I don’t propose penalties to be eliminated. I just want to bring them in line with current practice.”

In addition to these two bills the other bill to advance were:
  • HR 938: Blocking Act of 2019, which could save as much as $1.8 billion by reforming the 180-day exclusivity for first generics that may not come to market immediately because of application deficiencies.
  • HR 1520: Purple Book Continuity Act, which would reform the reference guide on biosimilars to include new patent and other information.
  • HR 1503: Orange Book Transparency Act, which would clean up the reference guide for generic drugmakers by removing invalid patents and adding new drug delivery device patents.


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