US Health Policy: FDA Calls for Federal Investigation of Itself on Aduhelm; Funding Boost for Medicare, Medicaid, ObamaCare; Questions over Benefits of New Science Agency


The latest from US health care policy, including the Senate budget deal funding for a range of major health care priorities; Biden’s proposed Advanced Research Projects Agency that would reshape the government’s medical research efforts; the Senate Finance Chair’s proposal to lower prescription drug prices; the FDA’s internal investigation into the Biogen Aduhelm approval; and a new Wall Street-like funding model for medical research.


Top U.S. Officials See Booster Shots as Inevitable

Biden administration health officials believe the most vulnerable Americans will eventually need coronavirus booster shots — but they are still debating how quickly that should happen, two administration officials said.

The internal deliberations have stretched on for months as health officials watch for signs of waning immunity among the vaccinated. The talks have included extensive behind-the-scenes coordination between the administration and drug companies manufacturing Covid-19 vaccines.


BioBonds Would Use Wall St. Tools to Fund Medical Research

Karen Petrou invented a new funding model for curing blindness. Proposed legislation aims to apply it to medical research more generally.

The program would create low-interest, government-backed loans for translational research. These would be packaged into a bond, similarly to how mortgages are, and sold into the secondary market for risk-averse institutional investors like pension funds.

In May, Representative Bobby Rush, Democrat of Illinois, and Representative Brian Fitzpatrick, Republican of Pennsylvania, introduced legislation that, if passed, would create $30 billion worth of these loans over three years.


D.A. Seeks Investigation of Its Own Alzheimer’s Drug Approval

The Food and Drug Administration called for a federal investigation of the process that led to the approval of a new drug for Alzheimer’s disease that has spurred sharp criticism from lawmakers and the medical community.

In a letter to the Department of Health and Human Services’ independent Office of the Inspector General, the F.D.A.’s acting commissioner, Dr. Janet Woodcock, acknowledged the scrutiny the agency has faced about the approval process for the drug, which is known as Aduhelm and has a $56,000 annual price tag. She pointed to interactions between representatives from the drug’s developer, Biogen, and the agency, saying some “may have occurred outside of the formal correspondence process.”


Cleveland Clinic and Mount Sinai Won’t Administer Biogen’s Aduhelm to Patients

In a striking reflection of concern over the approval of the controversial new Alzheimer’s drug Aduhelm, two major American health systems have decided that they will not administer it to patients.

The Cleveland Clinic, one of the largest and most respected medical centers in the country, said in a statement that a panel of its experts had “reviewed all available scientific evidence on this medication,” which is also called aducanumab.


Senate Budget Deal to Provide New Funding for Medicare, Medicaid, ObamaCare

The $3.5 trillion budget deal reached by Senate Democrats will include funding for a range of major health care priorities, from expanding Medicare and Medicaid to extending enhanced ObamaCare subsidies.

The proposal will also be paid for in part by lowering prescription drug prices, according to a senior Democratic aide. The budget deal would provide funding to add dental, hearing and vision coverage to Medicare, a major expansion pushed by progressives like Senate Budget Committee Chairman Bernie Sanders (I-Vt.).


Senate Finance Chair Releases Principles for Lowering Prescription Drug Prices

Senate Finance Committee Chairman Ron Wyden (D-Ore.) on Tuesday released principles for his proposal to lower prescription drug prices, saying current costs are “unacceptable.”

Wyden has been working behind the scenes to craft a bill to lower drug prices that can get all 50 Senate Democrats on board so that a measure can pass the chamber, as Republican support is not expected.


WH Press Secretary: Biden Unmoved on Marijuana Legalization Despite Schumer Legislation

President Joe Biden still opposes marijuana legalization, White House press secretary Jen Psaki said Wednesday, putting him at odds with Democratic leadership on Capitol Hill as it advances legislation to end the federal prohibition on pot.

Senate Majority Leader Chuck Schumer unveiled draft legislation Wednesday that would legalize marijuana as well as expunge non-violent criminal records related to marijuana.


Skeptics Question If Biden’s New Science Agency Is a Breakthrough or More Bureaucracy

The proposed Advanced Research Projects Agency would deliver breakthrough treatments for cancer, Alzheimer’s, diabetes and other diseases and reshape the government’s medical research efforts, by adding a nimble new agency modeled on the Pentagon’s Defense Advanced Research Projects Agency, or DARPA, which laid the groundwork for the internet.

But the way Biden would make “ARPA-H” and its $6.5 billion budget part of the sprawling National Institutes of Health is raising concern within the research community and in Congress about whether it will bring a new approach to old problems or become a duplicative bureaucracy with a lofty mandate.


Pandemic Fueled Deadliest Year for Drug Overdoses, CDC Data Shows

U.S. drug overdose deaths hit a new record of more than 93,000 last year, according to new data from the Centers for Disease Control and Prevention. There were 93,331 overdose deaths in 2020, the data show, an almost 30 percent jump from 2019.


President Biden Directs Moves on Drug Importation, Calls for Plan to Lower Drug Prices

President Biden on Friday directed the Food and Drug Administration (FDA) to work with states on importing prescription drugs from Canada, and called on officials to develop a “comprehensive plan” to lower drug prices in 45 days.

The moves are part of the health care section of a wide-ranging executive order on promoting competition in the economy that Biden signed on Friday afternoon. Allowing imports of cheaper drugs from other countries was part of Biden’s health care plan during the campaign, but Friday’s move is a step toward action on that front.


The Supreme Court Saved ObamaCare. Now Supporters Want Biden to Fix The Law

After the latest Supreme Court ruling on Obamacare secured its survival, some of the law’s staunchest supporters have a clear message on what President Joe Biden should do next: Fix it.

The Affordable Care Act, after more than a decade of political turmoil, has never loomed larger. The law provided a new safety net during the coronavirus pandemic, mostly through its expansion of Medicaid. The Biden administration has boosted federal aid to purchase Obamacare coverage, which could help bring in millions of new customers. Insurers who fled the marketplaces in the law’s turbulent early years have returned, lured partly by the richer government aid.

Health care policy experts are warning that the centerpiece of Obamacare, its heavily subsidized health insurance marketplaces where roughly 11 million people get coverage, has always lacked the kind of critical government oversight necessary to ensure the law lives up to its promises.

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