FDALegislativeWatch

CDC Plans Study Of Prescription Drug Monitoring Programs Next Year

The Centers for Disease Control and Prevention will undertake a study in 2008 on both prescription drug misuse fatality rates and prescription drug monitoring programs, CDC Medical Epidemiology Len Paulozzi said Oct. 24.

Device Firms Would Have To Report Sales Prices To CMS Under Senate Bill

A bill introduced Oct. 23 in the Senate would require device makers seeking Medicare reimbursement to report to CMS the prices they negotiate with hospitals and other buyers for all implantable medical devices.

Vitamins, Supplements Added To Food Stamp Program In Senate Farm Bill

The Senate Agriculture Committee on Oct. 25 added multivitamins and other dietary supplements to food stamp coverage in legislation to reauthorize federal farm subsidy programs.

CMS Maintains Status Quo On Clinical Trial Coverage, Again

Under intense pressure from Congress, industry and the medical research community, CMS has decided to maintain the status quo for coverage of routine costs in clinical trials.

Languishing NASPER Controlled Drugs Tracking Law Draws House Scrutiny

A federal law to better monitor controlled substances and help states work together to prevent drug diversion has yet to be implemented more than two years after enactment.

PTO Hit With Second Lawsuit Opposing Continuation Rules As GSK Joins Fray

GlaxoSmithKline has filed suit against the Patent and Trademark Office to block new rules limiting the number of continuation applications a patent holder can file.

BIO CEO Jim Greenwood: An Interview With "The Pink Sheet"

Biotechnology Industry Organization CEO Jim Greenwood sat down for an exclusive interview with "The Pink Sheet" at the BIO Investor Forum in San Francisco Oct. 10. Greenwood, a former member of the U.S. House of Representatives who chaired the Energy and Commerce Committee's Health Subcommittee, discusses the state of follow-on biologics legislation, concerns over pending patent reform legislation and the impact FDA reform legislation will have on the industry.

Senate Committee Will Hear Device Concerns With Physician Payment Bill

The Senate Special Committee on Aging plans to hold a hearing in the coming months on a bill that would require device and drug makers to disclose financial relationships with physicians.

Report Confirms China Food Safety Flaws, Suggests Cautious Cooperation

House Energy and Commerce Committee investigators confirmed flaws in China's food safety oversight, but also recommended the U.S. consider recognizing the country's system for approving products to be exported, according to testimony at a subcommittee hearing Oct. 11.

FDA Reform Bill Will Keep Firms Scrambling To Stay Ahead On Safety Issues

Pharmaceutical companies need to immediately begin assessing whether their drugs are subject to the risk evaluation and mitigation strategies provisions of the FDA Amendments Act, participants were warned during a Food and Drug Law Institute audioconference on the new law, Oct. 4.