The leaders of the Senate Health, Education, Labor and Pensions have released draft healthcare legislation for comment. The Lower Health Care Costs Act of 2019 contains five titles, one of which is titled Lowering the Costs of Prescription Drugs. This title contains sections meant to speed the introduction of biosimilars to the the market; to reduce abuses of citizen petitions to block generic entry; to enhance the transparency of IP for biologics through changes to the Purple Book; and to “modernize” the Orange Book.

Comments are due by Wednesday, June 5.

For more, see the press release, which includes links to the text, one-pagers, and a Section-by-Section analysis. The Section-by-Section for Title 2: Lower the Cost of Prescription Drugs, is pasted below.

Lower Health Care Costs Act

Title II: Reducing the Prices of Prescription Drugs

Sec. 201: Biological product patent transparency.

  • Increases transparency of patent information for biological products by requiring information to be submitted to the Food and Drug Administration (FDA) and published in the “Purple Book.”
  • Codifies the publication the “Purple Book” as a single, searchable list of information about each licensed biological product, including marketing and licensure status, patent information, and relevant exclusivity periods.
  • Requires the Secretary, in consultation with the Director of the U.S. Patent and Trademark Office, to publish a list of any holders of biological product licenses that failed to submit such information.

Sec. 202: Orange Book modernization.

  • Clarifies the information that FDA must include in the Orange Book about patents and exclusivities for drugs approved under Section 505 of the Federal Food, Drug, and Cosmetic Act.
  • Requires FDA to remove patents and patent claim information from the Orange Book when the U.S. Patent and Trademark Office determines a patent or patent claim is invalid or inoperative to encourage drug development in the area no longer patented.

Sec. 203: Ensuring timely access to generics.

  • Maintains the use of citizen petitions to allow interested stakeholders, including drug companies, to notify FDA of concerns with pending generic and other follow-on drug applications.
  • Addresses the abuse of the citizen petition process, which can be used to unnecessarily delay the approval of a drug application.
  • Provides that FDA may deny a citizen petition that is submitted with the primary purpose of delaying the approval of an application and clarifies criteria that FDA may use to make this determination.
  • Requires a petition to be submitted within 60 days after the petitioner knew, or reasonably should have known, the information that forms the basis of the petition.
  • Requires HHS to establish procedures for referring a petitioner to the Federal Trade Commission if determined that a petition was submitted with the primary purpose of delaying the approval of another application.

Sec. 204: Protecting access to biological products.

  • Clarifies that biological products, including insulin products, that will transition from the drugs pathway to the biologics pathway in March 2020, cannot receive new, extended market exclusivities.
  • Preserves certain unexpired exclusivities for biological products as FDA transitions the regulation of such products from the drugs pathway to the biologics pathway.

Sec. 205: Preventing blocking of generic drugs.

  • Prevents first-to-file generic drug applicants from blocking, beyond a 180-day exclusivity period granted by FDA, the entrance of subsequent generic drugs to the market.
  • Triggers the start of the first-to-file generic drug applicant’s 180-day exclusivity when a subsequent applicant has been tentatively approved and the first-to-file applicant has not received final approval within 30 months of submission of its application.

Sec. 206: Education on biological products

  • Requires FDA to establish an internet website to provide educational materials for health care providers, patients, and caregivers on biological products, including biosimilar and interchangeable biological products.
  • Provides that the Secretary may develop and improve continuing medical education for health care providers regarding biosimilar biological products.

Sec. 207: Biological product innovation.

  • Excludes all biological products subject to regulation under the Public Health Service Act from requirements to follow U.S. Pharmacopeial compendial standards, which were originally drafted to apply to drugs approved under Section 505 of the Federal Food, Drug, and Cosmetic Act.
  • Prevents delays related to compliance with USP standards, in the licensure of biosimilar and interchangeable products.

Sec. 208: Clarifying the meaning of new chemical entity.

  • Clarifies that eligibility for five-year new chemical entity (NCE) exclusivity is available only for a drug containing no active moiety that has been previously approved in the United States
  • Ensures that only the most innovative or novel drugs qualify for NCE exclusivity.

Sec. 209: Streamlining the transition of biological products.

  • In March 2020, a small subset of biological products, including insulin, will transition from the drugs pathway to the biologics pathway, opening the biological products up to biosimilar competition.
  • Ensures that marketing applications submitted six months prior to the transition that are still under FDA review at the time of the transition date will not have to be resubmitted, avoiding delays in product availability.