HELP to Vote on FDA Nominee Dec. 3

Senate HELP Committee Chairman Lamar Alexander (R-Tenn.) stated that he intends for his panel to vote on the nomination of Stephen Hahn, M.D., to be Commissioner of Food and Drugs on December 3, when lawmakers return from Thanksgiving recess. Chairman Alexander expects the full Senate to hold a confirmation vote before the end of the year. During his nomination hearing before the HELP Committee last week, Dr. Hahn faced questions on a wide range of health-related subjects, including over-the-counter (OTC) monograph reform, drug pricing and availability, regenerative medicine and stem-cell therapies, and non-opioid pain management. HELP members on both sides of the aisle, however, expressed particular interest in the nominee’s stance on a previously announced but stalled administration policy to ban favored e-cigarettes.

Lawmakers Raise Concerns about Cancer Drug Shortage

Reps. Cindy Axne (D-Iowa) and Anthony Gonzalez (R-Ohio) have written to the U.S. Department of Health and Human Services (HHS) requesting details about the shortage of vincristine, a pediatric cancer drug. The lawmakers cite reports from the Food and Drug Administration (FDA) that a critical shortage of the treatment is expected to last until December or January. Pfizer Inc. become the sole manufacturer of vincristine after Teva Pharmaceutical Industries Ltd. exited the market in July 2015. On November 13, Teva announced that it will resume production of the anti-cancer chemotherapy drug "as early in 2020 as possible."

Democrats Seek Answers on HealthCare.gov Technical Issues

A group of congressional Democrats are voicing concerns about recent reports of technical difficulties in the federal health insurance exchange online platform. The reports suggest that as many as 100,000 fewer people may have signed up for coverage on the first day of open enrollment due to technical failures. The lawmakers have called on the HHS to explain how the problems may have impacted HealthCare.gov early in the new enrollment season, arguing that “these errors may have prevented some consumers from completing their enrollments as intended during an already abbreviated open enrollment period and created further barriers for people to access health coverage.” A spokesperson for the Centers for Medicare and Medicaid Services (CMS) has said that the problems, which stemmed from technical changes made ahead of open enrollment, have already been fixed. The letter was signed by Senate HELP Committee Ranking Member Patty Murray (D-Wash.), Senate Finance Committee Ranking Member Ron Wyden (D-Ore.), House Energy and Commerce Committee Chairman Frank Pallone (D-N.J.), House Education and Labor Committee Chairman Bobby Scott (D-Va.), and House Ways and Means Committee Chairman Richard Neal (D-Mass.).

E&C Dems Request Briefing on Ascension/Google Partnership

Democratic leadership of the House Energy and Commerce Committee have written to the Chief Executive Officers (CEOs) of Ascension and Google to request briefings in light of recent reports that the health system shared the information of tens of millions of patients with Google under an initiative called Project Nightingale. The Wall Street Journal reports that Project Nightingale will collect and consolidate patient health data for multiple purposes, including the development of artificial intelligence tools. The lawmakers express concerns about the protection of patient privacy and personal user data. They request details on what data Ascension is sharing with Google, how much data is being used and shared, the extent to which Google employees have access to this information, the extent to which patients were informed about the use and sharing of their data, and what steps are being taken to protect the privacy and security of that data. The letters were signed by Chairman Frank Pallone (D-N.J.), Health Subcommittee Chairwoman Anna Eshoo (D-Calif.), Oversight Subcommittee Chairman Diana DeGette (D-Colo.), and Consumer Protection Subcommittee Chairwoman Jan Schakowsky (D-Ill.).

Lawmakers Question Impact of Private Equity on Nursing Home Quality

A group of Democratic lawmakers have sent letters to four private equity investors in companies that provide nursing home care and long-term care services. Sens. Elizabeth Warren (D-Mass.) and Sherrod Brown (D-Ohio), along with Rep. Mark Pocan (D-Wis.), express concerns about reports showing the negative impact of private equity firms on nursing home quality of care. The letters, set to Carlyle Group, Formation Capital, Fillmore Capital Partners, and Warburg Pincus, request information about the firms’ management of the long-term care facilities that they own.

Fentanyl, Narcan Prices Discussed at Opioids Roundtable

The House Heroin and Opioids Task Force convened a roundtable last week to discuss the intersection of the opioid epidemic and the criminal justice system. Top federal and state officials were in attendance. Office of National Drug Control Policy (ONDCP) Director Jim Carroll attested to the decrease he has observed in the amount of wholesale quantities of drugs entering the country from China but expressed concerns about the rate at which fentanyl continues to come into the U.S. The varying cost of Narcan across the nation was also discussed, along with the drug’s role in combatting the opioid crisis.

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