FDA intends to monitor recall effectiveness more closely following recommendations from a contractor’s study conducted in response to pressure from the White House, Congress and the media.
McKinsey & Co
McKinsey & Co’s. study recommends FDA accelerate internal communications about recalls and consider outsourcing audit checks to follow-up on more. FDA commissioned the study after the heparin recall in 2008 and the peanut products recall in 2009 revealed flaws in the agency’s system.
FDA intends to monitor recall effectiveness more closely following recommendations from a contractor’s study conducted in response to pressure from the White House, Congress and the media.
McKinsey & Co
Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.
The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package.
US trade and tariff leverage might successfully push European and other countries to pay more for medicines, but if not, President Trump’s executive order includes potential US drug withdrawal and other options to entice industry to lower US prices.
Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.