Although the Department of Health and Human Services (HHS) would, as a whole, see its revenue decrease slightly under the president’s nearly $4 trillion budget, the FDA and National Institutes of Health (NIH) could be in line for healthy increases.
With the comment deadline only a few days away, opposition to the Centers for Medicare & Medicaid Services’ (CMS) proposed changes to the Medicare Advantage and Part D prescription drug programs is boiling over.
With the Internet and globalization making counterfeit drugs an enticing opportunity for international organized crime and a way to fund terrorism, the U.S. needs to step up the certainty and the severity of punishment for dealing in counterfeit and unapproved drugs.
Despite deep disagreement over some provisions in a proposed Medicare Part D rule, lawmakers on both sides of the aisle opposed the Centers for Medicare & Medicaid Services’ (CMS) proposal to remove immunosuppressants and antidepressants from protected class status.
While the biopharma industry once again wants Canada placed on the U.S. Trade Representative’s priority watch list because of its policies that erode the value of drug patents, Eli Lilly and Co. has taken the matter into its own hands.
A rash of recent inspections that led to FDA enforcement actions against a number of Indian biopharma companies doesn’t mean the U.S. agency is targeting drugmakers in that country.
Given the growing importance and prevalence of fixed-dose combination (FDC) drugs, the FDA is rethinking the exclusivity for those that combine a new chemical entity (NCE) with previously approved components.
Drugmakers, patient advocacy groups, insurance companies and medical associations are lining up en masse in opposition to proposed changes to Medicare Part D that focus on the bottom line.
The FDA has cleared 13 drugmakers for the test run of its Secure Supply Chain Pilot Program. Each company along for the ride will get expedited entry for up to five approved drugs or APIs imported into the U.S. over the next two years.
