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Two key House Democrats are opening a joint committee investigation into Biogen’s new Alzheimer’s drug, saying its approval and high cost create questions about the regulatory process.
House Oversight and Reform Chair Carolyn Maloney (D-N.Y.) and Energy and Commerce Chair Frank Pallone (D-N.J.) said in a statement Friday they “have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit.”
The therapy’s $56,000 annual price tag is drawing increasing ire ahead of a government decision on reimbursement policies. The Food and Drug Administration granted Aduhelm an accelerated approval this month despite objections of an advisory panel that found a lack of clear evidence to show it could slow cognitive decline. Since then, three FDA panel members have resigned.
Biogen had conducted two large trials on the therapy with conflicting results. Following the FDA’s accelerated approval, the drug company has nine years to submit data on the drug’s efficacy, and will likely make billions of dollars from selling it over that span.
Medicare could spend $57 billion a year on Aduhelm, a Kaiser Family Foundation analysis found. The figure represents more than Medicare Part B spends a year on all other drugs combined, Maloney and Pallone said. The chairs said their panels will probe how it was approved, how the price was set, and “what impact this will have on research for future Alzheimer’s treatments and federal health care programs.”
Sens. Elizabeth Warren (D-Mass.) and Bill Cassidy (R-La.) have already called for a Senate Finance Committee hearing on the drug. Sen. Joe Manchin (D-W.Va.), a crucial vote in the Senate, said that FDA acting head Janet Woodcock should be quickly replaced with a permanent leader. Read more from Brody Ford.
Also Happening on the Hill
Vaccine Hesitancy: The House Select Coronavirus Crisis Subcommittee holds a hearing Thursday on vaccine hesitancy.
- Ag-FDA Funding Markup: The House Appropriations Committee on Wednesday is scheduled to mark up the fiscal 2022 Agriculture-FDA spending bill. The Agriculture-FDA Subcommittee last week advanced its $26.6 billion spending bill, which offers a more than 10% increase from 2021. Read more on the bill.
- Helms, Mexico City Policies Out of State Bill: The House Appropriations Committee released its fiscal 2022 State and Foreign Operations spending bill last night. The subcommittee will mark up the measure today and the full committee is slated to consider it Thursday. The bill does not include the longstanding Helms amendment, which bars funds to pay for abortion “as a method of family planning” or to “motivate or coerce any person to practice abortions.” It also would “permanently repeal” the Mexico City policy, according to a committee bill summary. The policy, since ended by Biden, previously barred federal funds for non-governmental organizations that offer abortion referrals. Read more details from Jack Fitzpatrick.
- Keep track of spending bill action using BGOV’s Status of Appropriations Table.
Health Bills on Tap: The House is scheduled today to consider several health-care measures under suspension of the rules—which bars amendments, limits debate, and requires a two-thirds majority for passage:
- Recognizing Covid-19 in India: The House would call on the administration to provide India with critical medical supplies to support the country’s Covid-19 response under H. Res. 402. The non-binding bill would also call on the White House to work with global partners to bring an end to the coronavirus pandemic.
- Global Health Security: The State Department would be directed to negotiate the establishment of a Global Health Security and Pandemic Preparedness Fund to fight and respond to global health crises under H.R. 391. The measure also would codify the Global Health Security Agenda Interagency Review Council. For more, see the BGOV Bill Summary by Christina Banoub.
Senators Want CFPB to Tackle Medical Debt: Sens. Chris Murphy (D-Conn.) and Chris Van Hollen (D-Md.) on Friday called on the Consumer Financial Protection Bureau to “address medical debt as Americans face steep bills, especially as a result of Covid-19,” according to a statement. The pair sent a letter to acting CFPB Director Dave Uejio, requesting his agency take steps to halt certain medical debt collection practices. Read their letter here.
The Coronavirus Pandemic
U.S. Halts Shipments of Lilly Antibody Drug: U.S. health officials paused distribution of Eli Lilly’s combination antibody therapy because of fears it won’t combat two increasingly common coronavirus variants. Resistance to the antibody treatment was seen among the gamma and beta variants of the virus, according to a statement from the Department of Health and Human Services. Medical providers should use treatments from Regeneron and GlaxoSmithKline instead, the officials said. Emma Court has more.
More Rapid Vaccines Seen for $6.5 Billion Medical Lab: Biden’s plan to incubate breakthrough biomedical discoveries in a new entity within the National Institutes of Health could lead to one of the largest shakeups to the medical research agency in at least 10 years. The proposed “Advanced Research Projects Agency for Health” would embrace the public-private partnership approach that was used to develop Covid-19 vaccines in record time. NIH Director Francis Collins speaks about ARPA-H to Jeannie Baumann.
- FDA Revises Vaccine Fact Sheet to Add Warning on Heart Risks
- Unions Push for Appeals Court Review of OSHA Virus Standard
WHO Says Delta ‘Most Transmissible’ Strain: The head of the World Health Organization warned that the delta variant is “the most transmissible of the variants identified so far” and has spread in at least 85 countries, the Associated Press reported. WHO Director-General Tedros Adhanom Ghebreyesus said at a press conference Friday that the lack of vaccines in poor countries has worsened the pace of transmission with the delta variant first seen in India, according to AP. Read more.
The Last–And Only–Foreign Scientist in the Wuhan Lab Speaks Out: Danielle Anderson was working in what has become the world’s most notorious laboratory just weeks before the first known cases of Covid-19 emerged in central China. Yet, the Australian virologist still wonders what she missed. The U.S. has questioned the lab’s safety and alleged its scientists were engaged in contentious gain of function research that manipulated viruses in a manner that could have made them more dangerous. Read more from Michelle Cortez.
More on the Delta Strain:
- Delta Variant Threatens to Destroy Another European Summer
- Sydney in Two-Week Lockdown as Delta Variant Infections Rise
- India Says Too Early to Judge Threat of Delta-Plus Covid-19 Variant
- Southern Taiwan Sees First Local Transmission of Delta Variant
- South Africa Faces Another Lockdown as Delta Variant Spreads
More Global Headlines:
- U.K.’s Large Events Test Shows No Substantial Virus Outbreaks
- Denmark Upholds Moves to Suspend AstraZeneca, J&J Vaccines
- Iceland Ends All Restrictions, With 87% of People Getting Shots
- Brazil Can Vaccinate All Adults by September, Suzano CEO Says
- Tanzania Admits to Third Covid-19 Wave but Still Gives No Data
What Else to Know
HHS Pulls Medicaid Work Rules in Two States: The U.S. Department of Health and Human Services continued its attack on work requirements in state Medicaid programs, informing Arizona and Indiana that it’s withdrawing approval for must-work provisions approved during the Trump administration. Requiring poor adults to work as a condition of receiving health care would likely hurt Medicaid enrollment without increasing employment, the HHS said. Read more from Christopher Brown.
J&J Settles N.Y. Opioid Suits for $263 Million: Johnson & Johnson said it agreed to pay $263 million to resolve opioid lawsuits filed in New York, settling the cases on the eve of the first U.S. jury trial over claims the company mishandled the highly addictive painkillers. Read more from Jef Feeley.
- Liver Study Results Show How Crispr Could Transform Treatment
- Makers of New Drugs Offered More Flexibility in Safety Reporting
- Medicare Home Health Payment Plan Clears White House Review
- Hospira Prevails in Competitor’s Epinephrine False Labeling Case
- Transgender Women Sue Georgia Medicaid for Surgery Exclusion
- FDA Won’t Meet User Fee Action Dates for Abbvie’s Arthritis Drug
To contact the reporter on this story: Brandon Lee in Washington at email@example.com