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October 23, 2014

Posts in "Drug Policy"

September 18, 2014

Friday Hearing Focuses on Antibiotic Resistance

One of the last events in Congress prior to lawmakers leaving for an election period recess break is a Friday morning House Energy and Commerce subcommittee meeting on the impact of the widespread use of antibiotics, featuring testimony from FDA drug development chief Janet Woodcock.  The liberal use of antibiotics in humans reportedly is causing bacteria to develop resistance to current antibiotic drugs and the House panel will mull efforts to spur development of new drugs.  Meanwhile, the White House this afternoon will announce new executive actions to combat antibiotic-resistant bacteria.

Separately, New York Democratic Rep. Louise M. Slaughter is pressing for the committee to also focus on health impact of animal antibiotic use and notes that antibiotic use in animals also contributes to increasing human antibiotic resistance.  Slaughter, who is spearheading a drive for legislation to force the Food and Drug Administration to monitor the issue, cites a recent Reuters report on agricultural uses of the drugs.  Earlier this month, Perdue Farms, a giant poultry processor,  announced that it has eliminated the use of antibiotics from its chicken hatcheries.

 

 

FDA Panels Examine Testosterone Treatment

Food and Drug Administration panels this week are mulling the impact of the expanded use of testosterone medicine. The New York Times reported Wednesday that a drug advisory panel voted overwhelmingly to curb the prescribing of testosterone to middle-aged and elderly men for unproven uses such as low energy and low libido. Today, the FDA panels weigh whether the agency should approve an easier to use capsule version of the hormone. Clarus Therapeutics aims to get approval of the capsule for use in a market that now features gels, patches, injections and a gum treatment. But the advisers at the first day of a two-day meeting in Hyattsville, Md., expressed concern about possible side effects associated with testosterone, linked by some studies to a higher risk of stroke and heart attack. It now is only approved by the agency for men with low or no testosterone stemming from specific medical conditions.

Details on the advisory panel debates are available in an  advisory memo and addendum, plus a drug industry response.

 

 

 

 

 

September 9, 2014

New Rules on Prescription Drug Disposal

The complexities of the prescription drug distribution system is illustrated today in final regulations from the Drug Enforcement Administration on the retrieval of remaining controlled prescriptions from medicine cabinets around the country. The remnant drugs left over from legitimate prescriptions poses an avenue for illicit redistribution or the possibility of overdoses. Congress mandated an improved drug disposal regulatory regime in legislation enacted 2010 and the DEA began the modification process in proposed rules published 2012.

Today’s 194 pages of regulations includes some streamlining of procedures and record keeping for drop-off points for unused controlled drugs at pharmacies, doctors offices, hospitals and other health care oriented locations, plus drug take-back events and mail-in programs. The rules also set a framework for a special type of reverse drug distributor who retrieves previous dispensed drugs. Of course, like the original distribution rules, the disposal rules include stringent record keeping and custodial requirements. The regulations do not apply to disposal of controlled substances from the stock rooms of hospitals and pharmacies, nor the retrieval illegal controlled substances not available through a prescription.

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By Paul Jenks Posted at 11:17 a.m.
Drug Policy

September 8, 2014

Report Documents Scope of Drug Abuse and Mental Illness

The Substance Abuse and Mental Health Services Administration last week released details on the scope of substance abuse and mental illness in the United States. The report notes that in 2013, 9.4 percent or 24.6 million persons over the age of 12 were illicit drug users, with marijuana use leading the tally with 19.8 current users. The agency estimated 4.5 million prescription pain drug abusers, 1.5 million cocaine and 595,000 methamphetamine users. A larger number of Americans – nearly 1 in 5 – had a mental illness in 2013 and 34.6 million sought mental health treatment and counseling. The tally of Americans suffering a serious mental illness, defined as interfering with major life activities, is estimated at 10 million (or 4.2 percent of the adult population).

Congressional action on drug abuse is complicated by several states legalizing recreational use of marijuana. Several other legislative efforts are pending to ramp up funding for programs to combat the abuse of prescription painkillers. HealthBeat’s Kerry Young reported in July that funding to aid state prescription monitoring programs could be included in this month’s temporary stopgap spending bill. Recent major mental health initiatives normally have been paired with other measures. The 2010 Affordable Care Act included mental health components and the 2008 financial services industry emergency bailout became law through a bill requiring insurance coverage parity for mental health services.

Roll Call Election Map: Race Ratings for Every Seat

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July 15, 2014

IRS’s Role in Health Care Law Is Targeted in House Spending Bill

The House today continues amendment votes on the fiscal 2015 Financial Services spending bill. Health care proposals in the legislation focus on the more than 40 provisions in the 2010 health care law that task the IRS with verifying consumer health insurance exchange subsidies, administering premium tax credits and enforcing the individual and employer health coverage mandates.

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July 14, 2014

Today’s Spotlight: House Health Bill Markup

The House Energy and Commerce Committee today begins a markup session on a batch of bills that would renew targeted health programs.

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July 7, 2014

What Will the FDA Do About Marijuana?

New York Gov. Andrew Cuomo has signed a bill legalizing the use of medical marijuana. The effort is part of a wave of state interest in allowing medical use of the highly controlled substance, while Colorado and Washington have opened up to recreational use of marijuana.

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