WASHINGTON, D.C. — In response to the House Judiciary Committee passing a legislative package that would stop REMS abuses, curb anti-competitive pay-for-delay deals, address sham citizen petitions, and regulate PBM spread pricing, David Mitchell, a cancer patient and the founder of Patients For Affordable Drugs Now, issued the following statement:
“We are encouraged by continued Congressional action to address an array of abusive tactics Big Pharma uses to block competition and keep drug prices high. I am grateful to Chairman Nadler, Ranking Member Collins, and members on both sides of the aisle for their work on one of the most critical issues facing Americans — skyrocketing prescription drug prices.
“We still have a long way to go to fix our broken system and lower drug prices for all Americans. Today’s actions are a step forward, but certainly not the last. We are eager to work with Congress to continue down this path of reform.”
Today’s hearing is the latest in a flurry of action on Capitol Hill to address what 8 in 10 Americans say is the “unreasonable” cost of prescription drugs. This year, the Senate Finance Committee, Senate Aging Committee, House Committee on Oversight and Reform, House Ways and Means Committee, and the House Energy and Commerce Committee have all held hearings or markups on the topic of skyrocketing drug prices. The latter two committees have both passed a bipartisan package of bills aimed at addressing Pharma abuses.
The topics included in today’s bipartisan-passed legislative package address:
REMS ABUSES: Brand drug companies use a safety program called Risk Evaluation and Mitigation Strategies (REMS) as a pretext for not selling drug samples to generic companies, which need the brand product in order to develop an equivalent and lower-priced competitor. The CREATES Act — part of today’s legislative package — would address delay tactics that are used by brand drug manufacturers to block lower-priced generic drugs. Taxpayers could save $3.9 billion by stopping this abuse, which the FDA has called “unfair and exploitative.”
PAY-FOR-DELAY: Brand drug companies pay off generic companies that plan to bring a competitor to market. In exchange for this payment, the generic manufacturer delays its product’s entry into the market and the companies share in the fruits of the extended monopoly. The Preserve Access to Affordable Generics and Biosimilars Act, passed by the Judiciary Committee today, would limit deals in which brand and generic drug manufacturers use anti-competitive pay-off agreements to delay cheaper generic and biosimilar drugs from reaching patients.
SHAM CITIZEN PETITIONS: Citizen petitions can be filed at the Food and Drug Administration requesting FDA action. But brand name drug makers filed 92 percent of all citizen petitions between 2011 and 2015 — all aimed at blocking cheaper generic drugs. The FDA denied more than 9 of every 10 of those petitions. Today, the Judiciary Committee took a step toward ending that abuse by passing the Stop STALLING Act.
PBM SPREAD PRICING: Pharmacy Benefit Managers, the drug pricing middlemen, rip off taxpayers and patients with a practice called spread pricing, in which PBMs retain the difference between what they bill insurers and employers and what they pay to pharmacies. States like West Virginia, Ohio, Arkansas, Connecticut, and Kentucky have already investigated or cracked down on spread pricing in state Medicaid programs. The Prescription Pricing for the People Act of 2019, passed by the Judiciary Committee today, would authorize the FTC to study reimbursement practices of PBMs and issue a report with policy recommendations.