Legislative Hearing Addresses 7 Bills That Target Generic and Biosimilar Competition

On Wednesday, the House Committee on Energy and Commerce held a Health Subcommittee legislative hearing on lowering the cost of prescription drugs. The 7 bills that were the subject of the hearing include several items of legislation that have long waited for congressional action as well as new proposals to address the need for increased competition.

Among the more well known of the proposals is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would allow a biosimilar or generic developer to bring a civil action against an innovator drug company if the latter refuses to make available enough samples of a product for testing. A parallel piece of legislation is also before the Senate.

While the CREATES Act has enjoyed broad bipartisan support since it was first introduced in 2016, the bill has languished without a vote after having received heavy opposition from the industry group the Pharmaceutical Research and Manufacturers of America, which says that the proposed legislation would expose brand-name drug makers to significant risk and hinder innovation.

The committee also considered a similar item of legislation, one that has also been awaiting action since 2014: the Fair Access for Safe and Timely Generics (FAST Generics) Act. This proposed legislation would amend the Federal Food, Drug, and Cosmetics Act to prohibit license holders of FDA-approved drugs or biologics from restricting availability of their products for testing by competitors who seek to develop generics or biosimilars. It would also stipulate that Risk Evaluation and Mitigation Strategies cannot restrict the supply of samples to generic or biosimilar developers.

A bill that has seen multiple iterations since it was first introduced in 2009 is the Protecting Consumer Access to Generic Drugs Act. This item of legislation would bar brand-name drug makers and generic or biosimilar developers from entering into pay-for-delay agreements that slow down the market entry of competitive products.

A bill targeting the generics market, the Fair and Immediate Release (FAIR) of Generic Drugs Act, first introduced in 2011, would allow a generic drug maker that either wins a patent challenge in court or is not sued for patent infringement by a brand-name drug maker to share in the 180-day exclusivity period for first generic filers. A second bill related to the 180-day exclusivity period is the Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act , which would discourage generic drug makers from delaying the start of their 180-day exclusivity period allowing the FDA to approve a second generic application prior to the start of the first applicant’s commercial marketing.

Finally, 2 bills are aimed at making patent information for drugs more readily available. The Orange Book Transparency Act would require that patents on small-molecule drugs that are invalidated through court litigation or by the Patent Trial and Appeal Board be removed swiftly from the Orange Books, and would require HHS and FDA to report to Congress their recommendations on the types of patents that should be listed. The Purple Book Continuity Act would require that the Purple Book, which addresses biologics, contain patent information similar in format and requirements to the Orange Book. It would also require that the Purple Book be available on the FDA’s website and be routinely updated.

During testimony, Anthony A. Barrueta, senior vice president of government relations at Kaiser Permanente, applauded the committee for considering the CREATES Act in particular, saying that the proposed law would help curb practices that hinder biosimilars. He added that Kaiser Permanente, which uses biosimilar infliximab (Inflectra) in 75% of patients, is particularly committed to garnering the cost savings offered by biosimilars, but “We cannot fully leverage our process to spark competition if generics and biosimilars are not available in the first place.”

The Association for Accessible Medicines’ president and chief executive officer (CEO), Chip Davis, Jr, also praised the CREATES Act, and added that Congress should pass the FAST Generics Act immediately. He also voiced AAM’s support of the proposed changes to the Orange Book and Purple Book, and called on Congress to take greater action on patent abuses, such as evergreening.

The BLOCKING Act received a less favorable review during testimony; Kurt R. Karst, JD, director of Hyman, Phelps & McNamara, P.C., called the bill unnecessary, and said that the FDA already has the authority to determine when 180-day exclusivity has been forfeited. He also questioned the merits of the FAIR Generics Act’s approach to 180-day exclusivity, saying that it could dilute the value of the statutory incentive. Davis agreed, saying that the proposals would have the unintended outcome of reducing competition.

Finally, Marc M. Boutin, JD, CEO of the National Health Council, reminded the committee that, while their legislative efforts are shining a light on some practices that are delaying access to biosimilars, they do not address misaligned incentives and lack of transparency in the drug distribution system. When insurers and pharmacy benefit managers have an incentive to include brand-name drugs on formularies while blocking biosimilars and generics, he said, patients miss out on savings.