Medical Devices and Prescription Drug Policy

The tax has proven unpopular, but was key to ensuring that the Obama healthcare law did not add to deficit.

A new bill to increase federal regulation of hydrocodone painkillers has already picked up 42 bipartisan cosponsors.

Reps. Vern Buchanan (R-Fla.) and Edward Markey (D-Mass.) are leading the charge in the House, introducing the Safe Prescribing Act on Wednesday, which would move hydrocodone medications – such as Vicodin – from a Schedule III to a Schedule II drug.

The move would put them in line with other painkillers such as morphine, fentanyl and oxycodone and require the patient to present a doctor’s written prescription in order to obtain the painkiller, among other protections.

The Supreme Court debated Tuesday whether patients should be able to sue when they're badly harmed by certain prescription drugs.

The court heard oral arguments over whether patients can sue drug makers on the grounds that their products were too dangerous to be prescribed.

Lawmakers who are anxious to see new restrictions on addictive painkillers have been warned by the Food and Drug Administration (FDA) not to expect quick action.

Reps. Vern Buchanan (R-Fla.) and Edward Markey (D-Mass.) sent the FDA a letter in January urging the agency to follow the recommendations of an advisory panel that voted in favor of moving hydrocodone from a Schedule III to a Schedule II drug. They said that action is needed to curtail an epidemic of prescription drug abuse.

In a response letter dated March 5 and obtained by The Hill, the FDA told the lawmakers that a number of regulatory hurdles remain before hyrdrocodone can be reclassified as a drug that requires a written prescription.

State attorneys general asked federal regulators Monday not to forget generic painkillers in their push for abuse-resistant opioids.

In a letter to the Food and Drug Administration, a group of 48 AGs described how addicts are moving toward drug formulations that have not been modified to discourage abuse.

The officials asked the FDA to "assure that generic [opioids] are designed with similar features" in order to avoid "deadly consequences." 

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The Justice Department is looking into blood thinner Plavix, which regulators have warned may increase the risk of heart attack and stroke for some people.

The blockbuster drug from French pharmaceutical company Sanofi prevents blood clots by interacting with an enzyme that might not be present in all patients, according to the Food and Drug Administration. 

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Federal railroad officials plan to begin testing conductors for common over-the-counter medicines after major accidents.

The Federal Railroad Administration (FRA) already tests conductors for controlled substances, but wants to add non-controlled substances, such as sedating antihistamines like Benadryl, to the list.

The Food and Drug Administration (FDA) is taking a new look at regulations that spell out which parts of a cow’s insides can be included in food supplements and makeup.

The agency is reopening the public comment period on a 2005 directive allowing certain previously prohibited cattle parts to be used in food, dietary supplements and cosmetics, according to a notice to be published in Monday’s Federal Register.

The head of a stakeholder group told the Food and Drug Administration (FDA) Wednesday that funding has not kept pace with the agency's ever-expanding portfolio.

Diane Dorman, president of the Alliance for a Stronger FDA, told the agency's Science Board that the current $2.5 billion budget is "dramatically less" than the FDA requires.

"This amount might have met the FDA's funding needs in late 2007 ... but not now," Dorman said. 

Medical device manufacturers vowed Tuesday redouble efforts to repeal the healthcare law's device tax as Congress faces a series of fiscal deadlines.

The Advanced Medical Technology Association (AdvaMed) told journalists  that it will try to attach repeal to a sequester replacement bill, the next continuing resolution, or as part of an overhaul of the tax code.

"We're going to double down on our repeal efforts," said AdvaMed President Stephen Ubl, citing House and Senate bills with fresh bipartisan support. "We're off to a strong start this year."