Medical Devices and Prescription Drug Policy

The bill is considered a must-pass and, so far, negotiators have been able to avert any major controversies.

The Senate Health Committee approved a must-pass bill Wednesday to reauthorize funding for the Food and Drug Administration and change the agency’s regulatory processes.

Congress must send the FDA bill to President Obama by Oct. 1, and lawmakers are trying to avoid the type of eleventh-hour debate that entangled the last reauthorization.

The Health, Education, Labor and Pensions (HELP) Committee approved its FDA legislation Wednesday by a voice vote. Sen. Bernie Sanders (I-Vt.) was the only “no” vote. In the House, the Energy and Commerce Committee is scheduled to vote next month on its version of the FDA reauthorization.

Congress has until Sept. 30 to reauthorize the user fees that fund Food and Drug Administration regulators.

House legislation reauthorizing FDA user fees contains a provision, written by Rep. Mike Rogers (R-Mich.), that would change the agency's mission statement to focus on job creation and economic growth, reports MedPage Today.

Repealing the healthcare reform law would put hundreds of federal jobs at risk, Politico reports.

Health insurance giant WellPoint is the latest target of an increasingly aggressive campaign to force disclosure of corporate political and lobbying expenditures, The Washington Post reports.

The debate over religious freedom is really about contraception, women's groups tell Kaiser Health News.

The Veterans Affairs Department is hiring an extra 1,600 mental health professionals, The New York Times reports.

With multiple deadlines looming, lawmakers have plenty on their healthcare plate as they return from their two-week Easter recess.

The House and Senate could unveil as soon as this coming week legislation updating the fees prescription drug and medical device makers pay to fund their regulators at the Food and Drug Administration. The Energy and Commerce Health subcommittee is holding a hearing Wednesday on the user fees and “how innovation helps patients and jobs.”

Current user fees expire Sept. 30 and the committees of jurisdiction — Energy and Commerce in the House and Health, Education, Labor and Pensions (HELP) in the Senate — had been hoping to start marking up legislation by month’s end.

The Food and Drug Administration said Monday it will work with certain makers of kidney-disease devices to speed up approval of their products and announced the winners among 32 applicants to the program.

The Center for Devices and Radiological Health's "Innovation Pathway" was first announced in February 2011 as a pilot program. The first batch of submissions was for brain-controlled, upper-extremity prosthetics.

The pathway program works within the existing regulatory framework, the FDA explains, while engaging with innovators earlier in the process in order to shorten the overall time and cost it takes for the development, assessment and review of breakthrough medical devices and to improve how FDA staff and innovators work together.

The United States would be looking at long-term budget surpluses rather than deficits if only healthcare costs per person were on par with the rest of the world, the nonprofit Center for Economic and Policy Research demonstrates with a new online calculator.

The think tank's "Health Care Budget Deficit Calculator" allows users to change the course of the nation's fiscal outlook by swapping healthcare costs with those of other industrialized nations, all of which have longer life expectancies than the United States. Simply by adopting Australian healthcare prices, the calculator shows, the deficit would be eradicated by 2040.

A second case of the counterfeit cancer drug Avastin reaching the U.S. market is focusing attention on the obscure overseas suppliers that are involved in shipping the medicines to U.S. doctors, The Wall Street Journal reports.

Federal food safety inspectors criticized a proposal by the Agriculture Department to allow private companies to take over the inspections at poultry plants, The New York Times reports.

Mississippi passed a bill that will require any doctor performing abortions in the state to be a board-certified OB-GYN with admitting privileges at a local hospital, Kaiser Health News reports.

Repealing President Obama's healthcare reform law would disproportionately hurt the credit ratings of for-profit hospitals, Modern Healthcare reports.

The chairman of the European Medicines Agency's main committee for approving new drugs resigned suddenly on Wednesday, Reuters reports.

The Senate panel with jurisdiction over the Food and Drug Administration on Wednesday released a discussion draft of legislation aimed at accelerating patient access to innovative medical treatments for life-threatening diseases.

The Health, Education, Labor and Pensions Committee's bipartisan Drug Approval and Patient Access Plan would overhaul the FDA's Accelerated Approval pathways and create a new "breakthrough" designation to provide more flexibility and certainty for developers of new medicines intended to address serious or life-threatening diseases or conditions.

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The private sector is moving full speed ahead with recommendations about unnecessary medical tests and procedures even as the healthcare reform law's investments in so-called "comparative effectiveness research" hang in jeopardy at the Supreme Court.