Roll Call: Latest News on Capitol Hill, Congress, Politics and Elections
October 23, 2014

Posts in "Pharmaceuticals"

October 21, 2014

DEA Clarifies Drug Wastage Disposal Rules

The Drug Enforcement Administration last month issued final regulations on the disposal of strictly controlled substances, such as prescription painkillers. The regulatory effort hopes to improve and expand on methods of disposing highly regulated substance and adjusts stringent record keeping requirements. The complex rules and record keeping requirements also seek to strictly control the custody of controlled substances. However, hospital groups complained that the new rules were unclear on accounting for unused portions — or drug wastage — from medicine administered to patients and is left over in syringes and IV solutions.

The DEA, in a memo released on Friday, clarified that the regulations do not consider any remaining leftover products used for patients in the hospital as part of the hospital’s drug inventory and subject to provisions of the new regulations.  The rules were designed to assist in collecting unused drugs in patients’ home medicine cabinets but the DEA did not intend for the disposal regulations to apply to hospital drug wastage.  However, the agency does urge hospitals to be careful and document the destruction of the drugs.

October 6, 2014

Reports Examine High Costs of Cancer Drugs and Identify New Carcinogens

Improvements and advances in cancer drugs have allowed cancer patients to begin cycles of home-based drug treatments that previously would have required intensive hospital care. However, a CBS Sixty Minutes report on Sunday explored the extremely high cost of the new cancer drugs. The report questioned researchers that cost of the drugs seems have become almost like another side effect from the cancer.

Meanwhile, the Department of Health and Human Services continues to identify environmental causes of cancer. The department today formally issues a report noting additions to the registry of cancer causing substances in the thirteenth annual report on carcinogens. The newly identified carcinogens include a substances used in cleaning solvents, fuels, tobacco smoke and telephone pole wood preservatives.

 

 

 

 

 

 

 

By Paul Jenks Posted at 3:34 p.m.
Pharmaceuticals

September 29, 2014

Payment Database Set to Document Physician Financial Relationships

Details emerge this week on the murky world financial relationships between physicians and drug manufacturers. The Department of Health and Human Services on Sept. 30 is slated to open access for the general public to a searchable database of payments to physicians and hospitals from the medical industry for research, consulting, meals, travel and other gifts. The 2010 health care overhaul law authorized the public database.

HHS notes that the disclosure of payments from health companies is not intended to signify an inappropriate relationship and that the law does nothing to prohibit such transactions. The relationships could contribute to the design and delivery of life-saving drugs and devices but also could influence physician health care treatment decisions.

CQ HealthBeat’s Kerry Young (@CQHealthTweet) reported last month that the American Medical Association sought to delay the release of the database. The doctors group noted that the registration process is cumbersome and the time required to review the information for accuracy should push the release into next year.

 

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.

 

 

August 1, 2014

Drug Coverage Premiums and Spending Forecast Remain Low

The Department of Health and Human Services  has announced a slight increase in the Medicare Part D program’s premiums for next year. The prescription drug benefit, first implemented in 2006, now offers drug coverage to 39 million people.

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July 29, 2014

Drug Naming Process Gets New Scrutiny From FDA

488548259 web 445x296 Drug Naming Process Gets New Scrutiny From FDA

(Oli Scarff/Getty Images)

The Food and Drug Administration on Monday issued a notice seeking comments on the process of naming prescription drugs, particularly drug manufacturers’ desire to reserve a specific name for a drug product.

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By Paul Jenks Posted at 10:30 a.m.
Pharmaceuticals

July 23, 2014

FDA Chief In India Departs

CQ HealthBeat’s Kerry Young reports on the departure of the Food and Drug Administration’s India office chief, Altaf Lal.

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July 15, 2014

Innovation: Fred Upton’s Committee Pushes for Ideas; Report Looks to 2025

The House Energy and Commerce Committee, led by Rep. Fred Upton, R-Mich., over the past few months has been busy examining a range of topics to assist in the development of new legislation to overhaul federal health programs to foster the development of new technologies and medical breakthroughs. The committee is in the process of examining the development and approval process for new drugs and devices. The effort continues later this week with a hearing on leveraging communications technologies.

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July 8, 2014

Rare Pediatric and Neglected Tropical Diseases: FDA Responds With Guidance

Capitol Hill asks for a lot of things in legislation, and federal agencies eventually do respond. The FDA issued reactions recently to two requests made in bills enacted prior to the current Congress.

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