Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose.
Reiterating prescription drug pricing provisions included in an executive order issued in July, U.S. President Joe Biden provided a bit of context and a little more detail about what he has in mind during a brief Aug. 12 speech on how his “Build Back Better” agenda would lower drug prices. Part of that agenda is to allow Medicare to directly negotiate prescription drug prices. “The only thing Medicare is not allowed to negotiate are prices for prescription drugs. My plan gets rid of that prohibition,” Biden said, adding that Medicare negotiates every other health care cost.
Instead of waiting for Congress to come up with a solution to reduce drug prices, a trio of U.S. lawmakers told the U.S. Department of Health and Human Services (HHS) it needs to tackle drug prices with the tools it already has – compulsory licensing and march-in rights.
Citing a unanimous U.S. Supreme Court ruling in April that denied the Federal Trade Commission’s (FTC) ability to seek restitution or disgorgement, the FTC, on July 30, withdrew its remaining count against Abbvie Inc. involving sham litigation intended to delay generic competition to its blockbuster testosterone replacement drug, Androgel.
As the COVID-19 pandemic continues to impact the FDA’s inspection program, U.S. lawmakers are worrying about what that may mean for future drug approvals.
“We are . . . concerned that we have not yet seen the full impact of delayed inspections, particularly in the case of preapproval inspections,” the bipartisan leadership of the House Energy and Commerce Committee and its Health Subcommittee said in a July 22 letter to acting FDA Commissioner Janet Woodcock.
Medicare coverage of telehealth services in the U.S. received a boost during the COVID-19 pandemic, a change that stakeholders have argued should be made permanent. The Centers for Medicare & Medicaid Services (CMS) has proposed to extend coverage of some of these services throughout calendar year 2023 in the draft Medicare physician fee schedule, but some stakeholders are urging Congress to act before the end of the year to make these benefits permanent.
Hoping to get Germany to drop its opposition to a proposed World Trade Organization (WTO) waiver of intellectual property (IP) rights, several U.S. lawmakers have asked to meet with German Chancellor Angela Merkel when she’s in Washington for a July 15 summit with President Joe Biden.
U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition.
The U.S. Federal Trade Commission (FTC) reported a series of moves recently that promise more scrutiny of companies in the life sciences industry, such as the more routine use of subpoenas and other compulsory processes during investigations. However, the FTC has also announced a broader revamp of the agency’s rulemaking authorities that some critics argue would allow the commission to promulgate rules that are in defiance of standing FTC practice.
The FDA’s recent release of documents related to its accelerated approval of Aduhelm (aducanumab) did little to reduce the controversy surrounding that decision and the U.S. pricing of Biogen Inc.’s Alzheimer’s drug.
