To Cut Drug Costs, FDA Paves Way For Easier Approval Of Copycat Biologics
The draft framework announced Wednesday lowers the standards that companies need to meet to bring the drugs to market. Also, states try to lower drug prices by regulating PBMs; how the immigration crackdown is affecting elder care; and more.
Stat:
FDA Proposes Easier Approvals For Biologics
The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic drugs to market with the aim of making medicine more affordable and accessible for patients. (Payne, 10/29)
More on the high cost of prescription drugs —
Modern Healthcare:
Insurers Push Back Against Single PBM State Models
States are getting creative to reduce Medicaid drug costs, with pharmacy benefit managers increasingly forced to adapt. This year, states including Minnesota, Nevada and Virginia enacted laws to use one PBM for their Medicaid managed care programs. They joined Ohio and Kentucky, which already have single PBMs, and more states have adopted comparable models or are considering similar approaches. Under this policy framework, a state contracts with a single PBM that operates pharmaceutical benefits for all Medicaid managed care plans and their members. (Tong, 10/29)
Modern Healthcare:
What Express Scripts' Drug Rebate Phase-Out Means For PBMs
Cigna’s decision to scrap controversial prescription drug rebates may be both a transformative moment for the pharmacy benefit manager sector and merely the latest stage in the industry’s evolution. Express Scripts, housed within Cigna’s Evernorth Health Services subsidiary, and leading pharmacy benefit managers such as CVS Health subsidiary CVS Caremark and UnitedHealth Group unit Optum Rx are recalibrating their business practices amid sustained fire from President Donald Trump, Congress, state legislators, regulators and smaller competitors. (Tong, 10/29)
In other news about the Trump administration —
Axios:
Trump Immigration Policies, Funding Cuts Worsen Rising Elder Care Cost
The cost of hiring help to care for an elderly or a sick person at home is skyrocketing. A labor shortage and surging demand from an aging population was already driving up prices, and now the White House's crackdown on immigration and funding cuts are making things worse. (Peck, 10/30)
The Hill:
Tobacco Industry’s Policy Interference On The Rise: Report
The tobacco industry’s influence on public health policymaking in the U.S. is growing according to the latest report by the anti-smoking organization Action on Smoking & Health (ASH). ASH’s Tobacco Industry Interference Index 2025, provided first to The Hill, found that the U.S. scored an 89 out of 100 on the Global Tobacco Industry Interference Index, a survey used to measure how governments respond the interference by the tobacco industry. The U.S.’s score ranked it 98 out of 100 surveyed countries. (Choi, 10/30)
NPR:
How Hurricane Relief Efforts In Jamaica Are Affected By The End Of USAID
It's a major international disaster. And it comes in the wake of the Trump administration's dismantling of the world's largest aid agency, the United States Agency for International Development, along with the slashing of billions of dollars in foreign assistance. Hurricane Melissa, the most powerful Atlantic storm of this year, has torn through Jamaica and several other islands in the Caribbean, leaving a trail of devastation. With major flooding and power outages, Prime Minister Andrew Holness has declared the country a "disaster area." (Tanis, 10/29)
Bloomberg:
US-China Trade War: Why Fentanyl Is At The Center Of Tariffs Fight
One of US President Donald Trump’s first actions against China following his re-election was to impose a 10% tariff on Chinese imports, punishing Beijing for what he described as its failure to curb illegal exports of fentanyl and the chemicals used to make it. Fentanyl — a powerful and highly addictive synthetic opioid — is often legally prescribed by doctors to treat post-surgery or chronic pain. But the drug, which is relatively cheap and easy to produce, is also found on the black market and its illicit versions have contributed to a rise in overdose deaths in the US over the past decade. (10/30)
Surgeon general nominee is scheduled for a virtual confirmation hearing today —
The Wall Street Journal:
The Surgeon General Nominee Who Wants To Make MAHA Moms Mainstream
Dr. Casey Means wants to give the Trump administration’s “Make America Healthy Again” agenda a less polarizing touch when she becomes U.S. surgeon general, a role where her experience as a new mother will be front and center. The wellness author, picked by Health Secretary Robert F. Kennedy Jr. to be surgeon general, was due to give birth to her first child Tuesday, just days before her expected virtual Senate confirmation hearing Thursday. (Essley Whyte and Siddiqui, 10/30)
