Senate HELP Committee Reaches a Deal on Drug Pricing Legislation
The Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy (R-LA) have reached a bipartisan deal on a slate of drug-pricing bills. The legislative package includes initiatives to spur generic drug approvals, cut fees from pharmaceutical middlemen, and cap the cost of insulin. Specifically, the bills under consideration are:
Ensuring Timely Access to Generics Act from Sens. Jeanne Shaneen (D-NH) and Susan Collins (R-ME) would empower the FDA to deny citizen petitions submitted either to primarily delay competition or that do not raise valid scientific or regulatory issues.
Expanding Access to Low-Cost Generics Act from Sens. Tina Smith (D-MN) and Mike Braun (R-IN) that would take on a practice called “parking.” Although companies that file first with the FDA to create the generic version of a drug are given 180 days of market exclusivity, the legislation would allow the next applicant to receive the exclusivity if the so-called first filer doesn’t bring the product to market in 75 days.
RARE Act from Sen. Tammy Baldwin (D-WI) that would specify that the seven-year orphan drug market exclusivity period would ban the approval of other drugs for the same approved use or indication, not the same disease or condition.
Pharmacy Benefit Manager (PBM) Reform Act from Sens. Sanders (I-VT) and Cassidy (R-LA) would ban PBM’s ability to charge health plans more for a drug than they reimburse pharmacies for dispensing it — a practice known as spread pricing. This would require that all rebates negotiated with drugmakers and fees collected by PBMs are passed through to plans, and mandating sweeping reports about their operations.
The HELP Committee will hold markups of these four bills on May 2nd. A hearing will also be held on May 10th at 1pm ET entitled “The Need to Make Insulin Affordable for All Americans.” The CEOs from the major insulin manufacturers and top executives from the major PBMs will testify including:
David Ricks, Chair and CEO of Eli Lilly and Company
Lars Fruergaard Jørgensen, President and CEO of Novo Nordisk
Paul Hudson, CEO of Sanofi
David Joyner, EVP and President of Pharmacy Services of CVS Health
Adam Kautzner, President of Express Scripts
Heather Cianfrocco, CEO of OptumRX
The hearing will be held in 216 Hart Senate Office Building. It will also be live-streamed on the HELP Committee’s website and Sanders’ social media pages. Constitution Partners will be monitoring both hearings and will keep our clients appraised of any updates once the Senate HELP Committee legislative package is released.