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Biden administration officials are committing to curbing patent practices that lead to high drug costs as Senate Democrats push ahead with a plan to lower pharmaceutical prices.
The US Patent and Trademark Office is now on the lookout for drugmakers trying to secure intellectual property protections on “incremental, obvious changes to existing drugs” that “unjustifiably delay generic competition,” according to a blog jointly penned by leaders from the PTO and Food and Drug Administration.
The two agencies are tasked with working together to lower drug costs via an executive order from President Joe Biden last July.
“Our patent system must not be used to unjustifiably delay generic drugs and biosimilar competition beyond that reasonably contemplated by law,” PTO Director Kathi Vidal and FDA Commissioner Robert Califf write.
Drug pricing has proved a tricky issue for the Biden administration and congressional Democrats. Senate Democrats just submitted a drug pricing proposal—for inclusion in a sweeping economic spending package—to the parliamentarian, according to a person familiar with the matter. Submission to the parliamentarian is the first step in the process to determine whether it meets budget-related criteria. Ian Lopez covers the latest in Democrats’ effort to tackle prices.
- Senate Democrats Finalize Prescription Drug Pricing Bill
- AstraZeneca Loses Bid to Dismiss Seroquel Pay-for-Delay Lawsuits
Happening on the Hill
Senators Call on Biden to Drop Marijuana Drug Classification: A group of Democratic senators demanded the Biden administration remove marijuana from the list of controlled substances and pardon anyone convicted of non-violent cannabis-related offenses. The request is a follow-up to an Oct. 6 letter asking that the Justice Department and the president exercise existing authorities. Sens. Elizabeth Warren (Mass.), Bernie Sanders (I-Vt.), Kirsten Gillibrand (N.Y.), Ed Markey (Mass.), Cory Booker (N.J.) and Ron Wyden (Ore.) sent the latest letter Monday to Biden, Attorney General Merrick Garland, and Health and Human Services Secretary Xavier Becerra. Jarrell Dillard has more from the letter.
States & Regulation
Kentucky Court Ruling Blocking Abortion Bans Stays in Effect: A state court order restoring access to abortion in Kentucky after the Supreme Court’s abortion ruling remains in force after the state supreme court declined to lift it. Read more from Mary Anne Pazanowski.
- Most abortions will be halted in Mississippi after a state trial court judge ruled that officials can enforce two laws banning the procedure in a case challenging their validity under the state constitution, a Mississippi trial court said. Mary Anne Pazanowski covers the latest on the case.
GOP AGs Support Alabama Ban on Medical Care for Trans Kids: Fifteen Republican attorneys general are urging the Eleventh Circuit to overturn a partial injunction against Alabama’s recently enacted law criminalizing gender-affirming medical care for children. Peter Hayes has an update on the ban.
Labcorp to Offer Monkeypox Testing as Part of Biden Expansion: Labcorp will offer testing for monkeypox, part of the Biden administration’s effort to make diagnosis more widely available as the virus spreads across the US and the world, Sri Taylor reports.
FTC Eyes Seldom-Used Pricing Law to Crack Down on Market Abuse: The FTC is mulling the use of a rarely used anti-price discrimination law to potentially crack down on dominant companies’ unfair use of market power. The Federal Trade Commission is ramping up enforcement against illegal bribes and rebate schemes involving pharmacy benefits managers, it announced in a June enforcement policy statement. The statement pointed to one of its legal authorities—the Robinson-Patman Act, a Great Depression-era price discrimination law referred to as the “Magna Carta of Small Business”—that could be exercised by the agency. Read more from Dan Papscun.
Juul Continues Selling Vaping Products After FDA Stays Ban: Juul Labs said it’s continuing to sell its vaping products after the Food and Drug Administration stayed an earlier ban on the smoking alternative, Robert Langreth reports.
Pharmacists Can Prescribe Pfizer’s Covid Pill Under FDA Order: Pharmacists will be permitted to prescribe Pfizer’s Paxlovid under a move by US regulators aimed at providing prompt access to the widely used Covid treatment. State-licensed pharmacists can prescribe Paxlovid to eligible patients, subject to certain limitations to assure appropriate treatment, the FDA said Wednesday in a statement. Read more from Robert Langreth.
Low-Deductible Health Coverage Gains Favor in Tight Labor Market: More than two-thirds of US employers are planning to enhance health and benefit offerings in 2023, according to benefits consulting firm Mercer. Mercer’s newly released survey of 700 employers found that 11% of employers are considering providing a medical plan with a low deductible or no deductible in 2023, and 41% already offer that option. Eleven percent offer free employee-only coverage for at least one medical plan, and another 11% are considering it. Read more from Sara Hansard.
- Hospitals Curbing Emissions Switch Anesthesia Gases, Plug Leaks
- Biogen Whistleblower Wins Favorable Pretrial Ruling on Kickbacks
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