Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

Largest generic drug company may join PhRMA

The trade association for brand-name drug manufacturers could soon count the largest generic drug maker among its members—and the brand-name companies aren’t entirely comfortable with the idea.

Nearly 600 U.S. clinics could be selling unregulated stem cell treatments

The risks of “stem cell tourism” might be overplayed, according to a new paper published June 30 in the journal Cell Stem Cell. But only because the real risks of unregulated stem cells might actually be within the U.S. 

1.6 million ACA exchange customers dropped out by March

Nearly 13 percent of the 12.7 million people who bought coverage on the Affordable Care Act’s health insurance marketplaces for 2016 had dropped out by the end of March.

AstraZeneca takes on FDA over Crestor patent

AstraZeneca’s cholesterol medicine Crestor’s patent protection is set to expire July 8, according to FDA standards, but the company has other plans for the drug. 

House committee subpoenas HHS over ACA reinsurance program

The House Energy and Commerce Committee has issued a subpoena to HHS Secretary Sylvia Burwell to turn over documents related to the Affordable Care Act’s reinsurance program, which Republican members on the committee claim has been improperly funded by the agency.

Biden rallies participants to double cancer progress in 'moonshot' kick-off

Vice President Joe Biden led a major step toward completing his “moonshot” task of curing cancer June 29, when he spoke at the first Cancer Moonshot Summit. 

FDA approves test for quicker detection of hospital ‘superbugs’

The Food and Drug Administration (FDA) has given a thumbs up to a test hospitals can use to identify certain types of antibiotic-resistant infections more quickly.

CMS’ Conway promises ‘adjustments’ to controversial Part B overhaul

While defending a proposal to test changes to how reimbursements are calculated under Medicare Part B, CMS Chief Medical Officer Patrick Conway, MD, told a panel of federal lawmakers the agency would alter the plan based on concerns from physicians and lawmakers.

Around the web

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

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