Are risk evaluation and mitigation strategies (REMS) actually making any difference when it comes to drug safety? Enquiring minds at the Health and Human Services' Office of Inspector General (OIG) want to know. The trouble is the FDA doesn't have the data to answer the question.

With sequestration set to trigger in less than three weeks, the FDA, National Institutes of Health (NIH) and other federal agencies are preparing for the worst while still hoping to be spared.

Although drugmakers will have to start tracking their payments to doctors and teaching hospitals in August under the Physician Payment Sunshine Act, the transactions will remain in the dark until late next year when the Centers for Medicare & Medicaid Services (CMS) opens the curtains and posts the data for all to see.

Having pioneered the biologics pathway, Amgen Inc. is broadening its stride so it can sprint down both sides of the track in the biosimilars race, hoping to cash in on what it sees as a multibillion-dollar opportunity.

Whether the nation's budgetary glass for the next few years is half empty or half full is more a question of "ifs," rather than perspective, according to the Congressional Budget Office's (CBO) latest outlook for fiscal 2013-2023. A number of those ifs depend, to some extent, on health care spending.

Hoping to gain some ground in an all-out war against superbugs, the FDA is taking the first steps toward creating an approval shortcut for new antimicrobials with a public hearing Feb. 4.

When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be. The article “Biotech Firms, Billions at Risk, Lobby States to Limit Generics” slams biotechs for encouraging states to adopt legislation limiting the automatic substitution of biosimilars, which the Times repeatedly called “generics.” As BioWorld Today reported, most of the bills being considered by states would require physician notification of what was substituted, enhanced recordkeeping and an opportunity for doctors (and, in...

While the FDA is still waiting for its first biosimilar application to be submitted, a few states – with the encouragement of patient advocacy groups and the biopharma industry – are already casting a safety net for when interchangeable biologics hit the U.S. market.

Even with grade inflation, the Department of Health and Human Services (HHS) and other federal agencies earned a "D" average for their efforts to request and respond to public comments when making major new rules. The grade dropped to an "F" for other rules.

With exclusivity assuming a bigger role in the life cycle of a drug, Gilead Sciences Inc. wants more for its Stribild HIV drug than the three-year exclusivity the FDA typically grants to new fixed-dose combination (FDC) drugs.