Health Subcommittee Considers Seven Bills to Promote Generic Competition

March 13, 2019

 

This afternoon, in a somewhat technical but very important hearing, the House Energy and Commerce's Health Subcommittee considered seven bills that would promote generic drug competition, reduce brand drug company manipulations of rules and regulations, and lower prescription drug costs.

 

The Committee's hearing focused on specific bills. The first is the CREATES Act (H.R. 965), which would establish a process by which generic drug manufacturers can get samples from brand companies in order to make more affordable medicines, and which allows legal action if brand drug companies adopt delaying tactics to prevent access to the samples. A second bill, the Fair Access for Safe and Timely Generics Act of 2019, establishes an authorization process through which generic drug companies can get access to samples that they are trying to use and make generic drugs. Another bill would ensure greater transparency and updated information in the Orange Book, which provides information about when patents or exclusivities for an approved drug expire. Still other bills would ban pay for delay settlements (where brand companies pay generic companies to delay bringing generic drugs on the market, so they can keep charging high prices)  and would discourage generic companies from delaying market entry of their products.

 

Rep. Ann Eschoo (D-CA-18) chaired the hearing and praised all the bills before the committee. She stated that they would promote generic drug competition and address barriers to generic development. Generic companies rely on samples in order to make their products, but brand companies have been abusing the process and refusing to provide them. Rep. Peter Welch (D-VT) urged members to come together in a bipartisan fashion-he mentioned that yesterday, during a budget hearing, Health and Human Services Secretary Alex Azar said he supported ending pay for delay settlements, curbing the abuse of citizen petitions, and stopping evergreening (small changes that drug companies make to drugs just to extend their patents or exclusive periods).

 

Rep. Frank Pallone (D-NJ-6), who chairs the full Energy and Commerce Committee, spoke about how drug prices are so high that nearly a quarter of Americans didn't fill prescriptions in the last year because of the costs. "My predecessors," he said, "very much believed that generics will lower prices and that generic competition is important, and I believe that as well."

 

Some Republicans were critical that the hearing was not sufficiently bipartisan. But the majority of Committee members, Democrats and Republicans, endorsed the CREATES Act and measures to promote access to samples, and criticized pay for delay agreements. Professor Michael Carrier of Rutgers University delivered eloquent testimony on how drug companies abuse regulations, and said the CREATES Act was an excellent bill that should be passed as soon as possible. He also told the Committee that pay for delay settlements, while not as widespread as they used to be, were still a problem and that Congress should pass H.R. 1499, which would outlaw them.

 

A couple of the other witnesses even attempted to defend pay for delay settlements as helpful to competition, or claimed that abuses weren't that bad. Professor Carrier politely but firmly rebuted them and said yes, the problem really is that bad.

 

The hearing was an excellent first step and Congress should pass these seven bills. But that alone will not be enough to lower drug prices and ensure consumers can get affordable medicines-we need more legislation to stop price gouging and hold drug companies and PBMs accountable. Fortunately, Committee members seemed well aware of this. Rep. Jan Schakowsky (D-IL-9), a senior Democrat, commented that they planned to hold hearings on additional bills, and she hoped her subcommittee could focus on the problem of evergreening. Hopefully the hearing is just the first on specific bills, and Americans will soon have access to affordable prescription drugs.

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