Medical Devices and Prescription Drug Policy
The FDA this week issued a rule that would allow women ages 15 and older to buy the emergency contraceptive.
The Food and Drug Administration (FDA) is under pressure from political activists — and some doctors — to remove all age restrictions on the over-the-counter sale of Plan B.
The FDA made waves Tuesday by allowing the sale of Plan B without a prescription to women 15 and older. Its previous policy had restricted the drug to patients 17 and older.
Women's-health advocates said the move from 17 to 15 was a good first step, but doesn't go far enough.
The American College of Obstetricians and Gynecologists said Wednesday that emergency contraception should be available without any age restrictions.
Emergency room visits involving a popular sleep medication more than tripled between 2005 and 2010, according to new government figures.
The Substance Abuse and Mental Health Services Administration (SAMHSA) found that zolpidem, Ambien's active ingredient, was behind about 19,500 ER visits in 2010 compared with 6,111 in 2005.
The discovery follows a recommendation from the Food and Drug Administration (FDA) that sleep aid manufacturers cut the recommended dose of products containing zolpidem for both men and women.
Sen. Charles Schumer (D-N.Y.) on Monday promoted his proposal to put stricter limits on several widely prescribed painkillers.
Schumer wants to reclassify hydrocodone, a drug used in painkillers such as Vicodin.
Schumer's bill, and a similar proposal in the House, would reclassify hydrocodone as a Schedule II drug, requiring a doctor's signature for new prescriptions and prohibiting automatic refills.
House lawmakers went another round with the chief U.S. drug regulator Tuesday over a deadly meningitis outbreak and how federal authorities should oversee the type of pharmacy that produced it.
Food and Drug Administration (FDA) Commissioner Margaret Hamburg pleaded with lawmakers for more authority to regulate firms like the New England Compounding Center (NECC), which made the tainted steroid injections that have killed 53 and sickened more than 700 since last fall.
Compounding pharmacies traditionally operate on a small scale by reprocessing drugs for individual patients with special needs. Some, like the now-shuttered NECC, pose challenges for regulators by creating and shipping specialty medications in mass quantities, akin to drug manufacturers.
The Food and Drug Administration had received "a litany of complaints" about the companies tied to a deadly meningitis outbreak, House Republicans said Monday.
Republicans on the Energy and Commerce Committee said the FDA had received specific complaints about the safety and sterility of drugs manufactured by the companies tied to the outbreak.
Energy and Commerce Republicans released more information from their meningitis investigation ahead of a hearing Tuesday at which FDA Commissioner Margaret Hamburg is scheduled to testify.
Fifty-two percent of respondents believe doctors should face limits in prescribing potentially addictive pain medications, according to a new poll, reflecting rising concerns about prescription drug abuse in the United States.
Advocacy coalition Research!America discovered widespread anxiety about prescription pain medications in its survey, with 85 percent of respondents expressing concerns that the drugs can be misused.
Nearly 50 percent described prescription drug addiction as a major U.S. health problem, while 63 percent said they know someone who has taken prescription medication to cope with severe pain.
The decision makes the morning-after pill available to women of all ages over the counter with no restrictions.
The U.S. pharmaceutical industry blasted India's Supreme Court Monday for denying a patent for cancer drug Glivec, saying the decision exposes the country's "deteriorating innovation environment."
The loss for Swiss drug maker Novartis is seen as a boon for local manufacturers and a bad sign for major pharmaceutical firms hoping to profit from India's rapidly growing drug market.
The Pharmaceutical Research and Manufacturers of America (PhRMA) scolded the high court in a statement, saying that intellectual property rights are "fundamental to the discovery of new medicines."