Medical Devices and Prescription Drug Policy

The manufacturers of medical imaging devices say a drop in the U.S. cancer rate shows the value of their products.

Congress and its Medicare advisory board often target imaging — services like MRI and CT scans — for payment cuts, arguing that doctors perform unnecessary tests. The rapid pace of new technology also keeps imaging prices high.

But imaging is central to a drop in cancer rates, the Medical Imaging & Technology Alliance (MITA) argued Thursday.

Federal regulators will require drug companies to cut the recommended doses for sleeping pills, saying the drugs cause lingering problems like the inability to safely drive a car.

The Food and Drug Administration (FDA) announced Thursday that it will require lower doses for drugs including Ambien, Edluar and Zolpimist. The drugs share the same active ingredient, which can cause morning-after drowsiness that interferes with the ability to drive safely.

New Obama administration guidance aiming to tamp down on prescription drug abuse is winning praise from GOP lawmakers.

Seeking to combat the widespread abuse of OxyContin, Vicodin and other potent painkillers, the Food and Drug Administration this week issued 24 pages of “nonbinding recommendations” to companies that manufacture opioid pills. 

Rep. Henry Waxman (D-Calif.) commemorated the 20th anniversary of the passage of the Orphan Drug Act Friday, calling it a “legislation that has proven successful beyond all expectations.”
 
The Orphan Drug Act was signed into law by President Reagan on Jan. 4, 1983, and created financial incentives for products that treated those afflicted with rare diseases.

In the decade preceding the law’s passage, there were only ten drugs developed to treat rare diseases, a situation that Waxman characterized as “a classic case of market failure.”

Sales of human growth hormone (HGH) rose 69 percent from 2005 to 2011, signaling the increasing popularity of a drug some believe will prevent aging and the likelihood that many doctors are ignoring strict rules on its use.

The Associated Press analyzed data collected by research firm IMS Health and found that sales of the average prescription drug rose much slower than those for HGH over the same period — only 12 percent.

The report charged doctors with prescribing the drug for uses outside of the few sanctioned by federal rules, such as treating short bowel syndrome or the rare Prader-Willi syndrome. 

A consumer advocacy group is criticizing the Food and Drug Administration (FDA) over its proposed two-tier framework for regulating drug compounders.

Public Citizen urged federal Health and Human Services Secretary Kathleen Sebelius Tuesday to reject the proposal and tell the FDA to use its existing authority to ensure compounding pharmacies are operating safety.

The group sent the letter to Sebelius a day before the FDA is scheduled to meet on the proposal. 

The Supreme Court said Friday that it will hear a case involving so-called "pay for delay" settlements between brand-name and generic drug companies.

The court will determine whether those settlements are a violation of antitrust law, as the Federal Trade Commission believes.

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House lawmakers criticized U.S. drug regulators Wednesday for failing to prevent an outbreak of fungal meningitis that has killed 32 people. 

Friends in Congress have helped drug compounders avoid tighter rules.

Avoiding the fiscal cliff likely means changes in Medicare.

Doc lawmaker seeks GOP conference chairman post [reg. req'd].

The House is looking to pass legislation this week that would legalize the sale of 1 million asthma inhalers, which were banned from drugstore shelves this year in order to comply with an international air quality treaty.

Republicans are expected to call up H.R. 6190, the Asthma Inhalers Relief Act, on Tuesday. The bill would allow the sale of about 1 million remaining Primatene Mist inhalers, despite a ban on the sale of this product since the end of 2011.