Over the coming days, Inside Health Policy will roll out a series of articles based on conversations with key stakeholders regarding their impressions of Gottlieb’s progress thus far, and where they see him taking the agency on key issues, including: off-label promotion, regulatory reform and drug pricing.
House Republicans want FDA to expand the Parallel Track pathway, which currently provides patients with HIV and AIDS drugs that have not been FDA approved but are being studied in clinical trials, to include potential therapies for debilitating diseases such as Alzheimer’s and cancer.
FDA took another step to help speed up access to generic drugs by publishing draft guidance that explains how drug makers can better use the Inactive Ingredient Database (IID) in drug development, including to evaluate the safety of inactive ingredients, also known as excipients.
Reckitt Benckiser Group, which used to own Suboxone maker Indivior, has agreed to pay $700 million to the federal government and $50 million to settle Federal Trade Commission charges that the company violated antitrust laws in an attempt to thwart generic competition to the opioid addiction treatment drug Suboxone.
Free-market think-tank Pacific Research Institute released a report Thursday (July 11) that pinpoints market practices -- such as low biosimilar reimbursement, step therapy policies and anti-competitive contracting practices -- and lack of education from FDA on interchangeability and biosimilar safety as the biggest obstacles to biosimilar competition.
House lawmakers have reintroduced a bill that would require FDA, in consultation with the National Institute on Drug Abuse (NIDA), to issue guidelines on the production of marijuana as part of the legislation’s larger goal to amend the Controlled Substances Act to make marijuana accessible to researchers for medical purposes.
FDA Principal Deputy Commissioner Amy Abernethy will discuss hemp production during a July 25 Senate agriculture committee hearing, the committee announced Wednesday (July 17).
The National Milk Producers Federation (NMPF) complained to FDA on Wednesday (July 17) that the agency has yet to resolve issues surrounding its standard of identity for milk, namely whether plant-based products should be called “milk.”
National Kidney Foundation leaders expressed hope signals from the White House that FDA, CMS and the Center for Medicare & Medicaid Innovation (CMMI) are interested in advancing renal replacement therapies or devices could encourage more investment in medical product development for kidney disease.
Sen. Kamala Harris is the latest Democratic presidential candidate to vow that Americans would not pay more for drugs than other countries pay, if she is elected.
Lawmakers and federal agencies tasked with monitoring illicit drug flow, including FDA and Customs and Border Protection, pinpointed a lack of data sharing among agencies as a challenge in combating the illicit flow of fentanyl into the United States.
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