Lawmakers Question Why HHS Hasn’t Worked Out Stalemate With Gilead Over Royalties For HIV Prevention Pill
The research done to create the life-saving pill was funded by taxpayer money, but talks have stalled about royalties so the government hasn't been able to collect. For its part, a Gilead spokesman said “there are no ongoing negotiations between Gilead and HHS” about patents owned by the government. In other pharmaceutical news: the fault lines in the Democratic party over drug prices; experts suggest its time to kill off copays; FDA taps a public health expert to lead its regulatory policy office; the FTC sues Surescripts; and more.
Stat:
Senators Push HHS To Move Against Gilead On An HIV Drug Patent
Several U.S. senators have asked the Health and Human Services Department to explain what, if any, steps are being taken to ensure that patents held by the federal government on an HIV prevention pill are properly licensed. The lawmakers also asked agency officials to demonstrate how they take into account whether medicines are affordable when considering licensing patents. The move comes as AIDS activists have criticized the Centers for Disease Control and Prevention for failing to reach a deal with Gilead Sciences (GILD) over royalties on its sales of the Truvada pill. (Silverman, 4/24)
The Hill:
House Dem Chairmen To Meet With Progressives Amid Drug Pricing Divisions
Two key House Democratic committee chairmen will meet with progressive House Democrats next week amid divisions in the party over how to craft their signature legislation to lower drug prices, according to House Democratic aides. House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) and House Ways and Means Committee Chairman Richard Neal (D-Mass.) will meet with members of the Congressional Progressive Caucus next week to discuss legislation to allow Medicare to negotiate drug prices. (Sullivan, 4/24)
Stat:
At A Lively Drug Pricing Debate, Experts Suggest Killing Off Copays
It was billed as a debate on sky-high prescription drug prices — but once again, middlemen known as pharmacy benefit managers took center stage. A panel of policy experts and biotech veterans who gathered at Harvard on Tuesday focused much of their ire on the role of insurance. Though they disagreed on plenty — like who is ultimately responsible for high drug prices — all concluded that people would probably be better off if the health care system killed copays, which some argue gives patients “skin in the game” that can keep them from using health services or drugs they don’t need. (Sheridan, 4/25)
Stat:
FDA Hires Pew Director To Lead Regulatory Policy
Elizabeth Jungman, a well-known public health expert and a Capitol Hill veteran, will lead the FDA’s regulatory policy office starting this summer, STAT has learned. Jungman, who currently serves as head of public health programs at the Pew Charitable Trusts, will direct the FDA’s Office of Regulatory Policy, a post with sweeping authority over FDA’s human drugs portfolio, two sources told STAT. The office is perhaps most known for its role in regulating drug compounding, although it has also led some of the FDA’s work on other hot-button issues like abuses of the agency’s safety systems and its regulation of homeopathic drugs. (Florko, 4/24)
Stat:
FTC Sues Surescripts, Alleging Illegal Monopoly In E-Prescribing
In its latest bid to rein in the health care industry, the Federal Trade Commission filed a lawsuit accusing Surescripts of illegally monopolizing the market for e-prescribing, which refers to transmitting patient information and prescriptions among insurers, doctors, and pharmacies. E-prescribing has becoming an important component of health care as public and private payers, as well as heath care providers, seek to streamline costs and speed important paperwork among key players. And Surescripts has been a dominant purveyor for more than a decade with a 95% market share, according to the lawsuit, which was filed on April 17 but disclosed by the agency on Wednesday. (Silverman, 4/24)
Stat:
Commerce Report Causes Stir On Using U.S. Law To Drop Drug Prices
At the same time the Trump administration has vowed to attack rising drug costs, the Department of Commerce has released a report that some academics and consumer advocates argue would restrain the ability of the federal government to limit “excessive” prescription drug prices. In a lengthy document that largely mirrors a draft report leased late last year, the department’s National Institute of Standards and Technology offers suggestions for modernizing technology transfer and innovation, and proposed several ideas for maximizing returns on taxpayer investment in R&D. (Silverman, 4/24)
Detroit Free Press:
More Michigan Cities Suing Big Pharma
Three Macomb County communities on Wednesday filed lawsuits against opioid manufacturers, distributors and prescribers, seeking damages for creating a public health crisis — and an economic burden — by getting its residents hooked on opioid pain relievers. Sterling Heights, Warren and Harrison Township filed their suits in Macomb County Circuit Court, saying drug manufacturers used deceptive marketing to promote the use of highly addictive opioid pills. In doing so, the communities join dozens of other Michigan cities and counties — including Detroit, Lansing, Grand Rapids, Pittsfield Township and Genesee, Grand Traverse and Macomb counties — involved in similar legal action. (Kovanis, 4/25)
Boston Globe:
MassBio’s Push To Soften Drug-Price Legislation Produces Plenty Of Drama
MassBio’s goal: to soften that language with a compromise measure, particularly limiting the public disclosure of that potentially sensitive pricing information. The members of the House of Representatives apparently agreed in the end, by voting overwhelmingly to approve the budget amendment put forward by MassBio on Wednesday. (Chesto, 4/24)
