FDA Plans Continued Support For Overseas Baby Formula Imports
The Wall Street Journal reports long-term imports are going to be supported by federal health regulators even after the current shortage is solved. The court battle between Juul and the Food and Drug Administration, AbbVie's tax situation, the pig-heart transplant and more are also in the news.
The Wall Street Journal:
FDA Will Help Overseas Baby-Formula Makers Keep Selling In U.S. Beyond Shortages
Federal health regulators are devising plans that would let overseas baby formula makers market their products in the U.S. long term beyond the current baby formula shortage. To ease shortages of baby formula, the Food and Drug Administration has been temporarily allowing foreign manufacturers to ship their products to the U.S. (Armour, 7/6)
In other pharmaceutical news —
AP:
Juul, FDA Suspend Court Case While E-Cigarette Ban On Hold
The Food and Drug Administration and Juul agreed Wednesday to put their court fight on hold while the government reopens its review of the company’s electronic cigarettes. The agreement comes one day after the FDA placed a hold on its initial order banning Juul’s products from the market, saying that Juul’s application warranted “additional review.” (Perrone, 7/7)
The Wall Street Journal:
Senate Report Hits AbbVie’s Bermuda Tax Structure For U.S. Humira Sales
Illinois-based AbbVie Inc. makes the bulk of its profits from arthritis drug Humira on sales in the U.S., but the company reports almost all its taxable income in foreign subsidiaries, according to a Senate Finance Committee report that criticizes the pharmaceutical company’s use of entities in Bermuda and Puerto Rico to reduce its tax burden. (Rubin, 7/7)
On drug prices —
Stat:
Here’s What Democrats Changed In Their Latest Drug Pricing Bill
Senate Democrats have put final tweaks on their drug pricing proposal, as they race to achieve one of their signature domestic policy promises ahead of the midterm elections. (Cohrs, 7/7)
KHN:
Seeking To Kick-Start Biden’s Agenda, Schumer Unveils A Bill For Medicare Drug Price Negotiations
Democratic senators on Wednesday took a formal step toward reviving President Joe Biden’s economic agenda, starting with a measure to let Medicare negotiate prices with drugmakers and to curb rising drug costs more broadly. A similar proposal died in December when Sen. Joe Manchin (D-W.Va.) decided to oppose Biden’s $1.9 trillion Build Back Better bill, which also included provisions allowing for Medicare drug negotiations. (McAuliff, 7/7)
In science news —
The Washington Post:
Pig Heart Recipient Died Of Heart Failure, Study Finds
Doctors at the University of Maryland School of Medicine have concluded that a man who received a first-of-its-kind pig-heart transplant in January died two months later of heart failure. The reasons for the failure remain under investigation. The man, David Bennett, was able to get out of bed, begin rehabilitation and spend time with his family in the weeks after the transplant at the University of Maryland Medical Center. His doctors say that makes the effort a success. (Cohn, 7/6)
Stat:
In Search For ARPA-H Director, White House Zeroes In On DARPA Vets
The White House is zeroing in on former DARPA officials as candidates to lead the Biden administration’s new high-stakes science agency, ARPA-H. (Facher, 7/7)
