Hearings/Markups

House Committee on Rules: Meeting on continuing appropriations for fiscal year 2020
The House Committee on Rules held a meeting to discuss H.R. 4378, Continuing Appropriations Act 2020 and Health Extenders Act of 2019. They agreed upon a rule for consideration of the Continuing Resolution. The CR passed the House on Sept. 18 by a vote of 301-123.  Find more information on the meeting here.

House Energy and Commerce Subcommittee on Consumer Protection and Commerce: “Profits over Consumers: Exposing How Pharmaceutical Companies Game the System”
The House Energy and Commerce Consumer Protection and Commerce Subcommittee held a hearing on product hopping in the pharmaceutical market. Find information for this hearing here.

Why this is important: Members used the hearing to highlight concerns over product hopping, also known as line extension and sometimes referred to as evergreening, referring to the reformulation of a pharmaceutical drug product by a brand drug manufacturer for the purpose of delaying competition. Chairman Frank Pallone (D-NJ) emphasized that profit made from drug sales is concentrated around only a few drugs with no competition; in 2017, only 10 percent of drugs were responsible for 72 percent of consumer spending on drugs.

House

House Passes Continuing Resolution to Fund Government Through Nov. 21, Include Health Extenders
On Sept. 18, the House passed a short-term continuing resolution (CR), H.R. 4378, to fund the government through Nov. 21, with a 301-123 vote. The Senate is expected to take up the CR this week. A package of health extenders was added to the CR. The CR funds community health centers and Medicaid in Puerto Rico and other territories at current levels. The CR delays a $4 billion reduction in Medicaid disproportionate share hospital (DSH) payments through Nov. 21. The CR includes a provision that was recommended from the Medicaid and CHIP Payment and Access Commission. That provision would exclude a manufacturer’s authorized generic drug price from the average manufacturer price of its brand product. The bill also would remove manufacturers from the definition of wholesaler in the Medicaid drug rebate program. The CR includes a short-term delay of the Medicaid DSH cuts. Follow more on H.R. 4378 here.

Education & Labor Committee Surprise Billing Markup Delayed by Payment Disputes, ERISA
On Sept. 18, the House Education & Labor Committee Chairman Bobby Scott (D-VA) said that his committee is sorting out technical issues to ensure its surprise billing fix applies to the Employee Retirement Income Security Act of 1974 (ERISA), as well as all other forms of health coverage, and that the committee is still debating on whether to use a benchmark payment rate or arbitration as the policy fix. Rep. Scott expects to introduce and mark up surprise billing legislation either immediately before or after the October recess.

Speaker Pelosi Introduces Drug Pricing Bill
On Sept. 19, House Speaker Nancy Pelosi (D-CA) released a drug-pricing bill that gives the Department of Health and Human Services (HHS) negotiation power over drug prices that apply to all payers, including the commercial market. The released bill directs HHS to negotiate prices on drugs without generic or biosimilar competition, while the earlier draft had price negotiation on drugs with less than two competing generics or biosimilars. The plan applies to drugs that meet two conditions—they are among the 250 most costly drugs to Medicare and the U.S. health system, and they face no competition. HHS would have to negotiate a minimum of 25 drugs annually. The maximum negotiated price would be set with an international price index, called the “Average International Market” price. The index would set a maximum price at 120 percent of the average of prices in six countries: Australia, Canada, France, Germany, Japan and the United Kingdom. If companies do not participate in the negotiation process or bargaining fails, drug makers would have to pay a fee of 65 percent of gross sales of the drug, which would increase by 10 percent with each quarter of noncompliance, to a maximum of 95 percent. The House Energy & Commerce Health subcommittee plans to hold a hearing on the drug pricing legislation on Sept. 25.

Senate

Appropriations Committee Favorably Reports $80 Million Increase for FDA to Senate Floor
On Sept. 19, the Senate Appropriations Committee favorably reported a bill to the Senate floor that gives the Food and Drug Administration (FDA) an $80 million funding boost in fiscal 2020, with investments in the FDA’s medical countermeasures initiatives, pathogen reduction efforts, compounding oversight, food safety and outbreak prevention, cannabidiol activities and infrastructure maintenance.

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