Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. “We don’t use our people as guinea pigs in the U.S.,” Shuren said, holding firm as the new director of the U.S. Food and Drug Administration’s medical devices division. Again and again in 2011—four times in…
FDA to Overhaul Long-Criticized Medical Device System
WASHINGTON (AP) — U.S. health officials said Monday they plan to overhaul the nation’s decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and medical instruments. The Food and Drug Administration announced plans aimed at making sure new medical devices reflect up-to-date…
U.S. Approves New Generic Competitor to EpiPen
U.S. health officials on Thursday approved a new generic version of EpiPen, the emergency allergy medication that triggered a public backlash due to its rising price tag. The new version from Teva Pharmaceuticals is the first that will be interchangeable with the original penlike injector sold by Mylan. The Food and Drug Administration announced the…
Insider Q&A: What’s Behind Rising Insulin Prices?
Rising prices for insulin are getting scrutiny from diabetes patients, physicians, and politicians. More than 7 million Americans with diabetes need insulin to control their blood sugar and stave off dangerous complications. The average price of insulin tripled between 2002 and 2013, according to the American Medical Association. The group recently called on regulators to…
To Get Around Pharmacy Gag Rules, Ask About Drug Costs
“Do you have prescription insurance?” It’s one of the first questions consumers hear at the pharmacy counter, and many hand over their insurance cards in the hopes of getting a good price. But sometimes using insurance can actually cost more—and even prevent the pharmacist from saying so. That’s because of so-called gag rules, which bar…
FDA Warns Teething Medicines Unsafe, Wants Them Off Shelves
Federal health officials warned parents Wednesday about the dangers of teething remedies that contain a popular numbing ingredient and asked manufacturers to stop selling their products intended for babies and toddlers. The Food and Drug Administration said that various gels and creams containing the drug benzocaine can cause rare but deadly side effects in children, especially…
Drug Epidemic Ensnares 25-Year-Old Pill For Nerve Pain
The story line sounds familiar: a popular pain drug becomes a new way to get high as prescribing by doctors soars. But the latest drug raising red flags is not part of the opioid family at the center of the nation’s drug epidemic. It’s a 25-year-old generic pill long seen as a low risk way…
US Experts Back Marijuana-Based Drug For Childhood Seizures
A medicine made from the marijuana plant moved one step closer to U.S. approval Thursday after federal health advisers endorsed it for the treatment of severe seizures in children with epilepsy. If the Food and Drug Administration follows the group’s recommendation, GW Pharmaceuticals’ syrup would become the first drug derived from the cannabis plant to…
FDA Puts Restrictions On Bayer Birth Control Implant But No Recall
U.S. health officials on Monday placed new restrictions on a permanent contraceptive implant that has been subject to reports of painful complications from thousands of women. But the metal implant, called Essure, will remain on the market. The Food and Drug Administration said only women who read and have the opportunity to sign a brochure…
FDA Chief Wants More Mail Inspectors To Stem Opioid Influx
The head of the Food and Drug Administration wants to more than double the number of packages his agency inspects for illicit drugs, an effort to stem a deadly flow of opioids that increasingly runs through the international mail supply. FDA Commissioner Scott Gottlieb said Monday he needs more staffers to intercept opioids that are…