Daily News

FDA has asked the Office of Management and Budget (OMB) to review a final rule requiring drug and biologics companies to submit professional labeling information in electronic format. Electronic submission would speed up the labeling review process and the approval of labeling changes, FDA says.

The rule, if cleared by OMB, would changes the submission format for labeling information, which is part of new drug applications, biological license applications, abbreviated new drug applications, supplements and annual reports.

The HHS Office of Inspector General (OIG) has proposed new standards for excluding providers from the Medicare program if they overcharge Medicare for products and services, such as durable medical equipment, drugs and laboratory tests, signaling the agency's intention to implement its 10-year-old exclusion authority for the first time.

The Sept. 15 proposed rule has drawn criticism from suppliers of durable medical equipment, who already face potential reimbursement cuts in the pending Medicare bills.

Medicare's controversial outpatient therapy caps are to remain in effect, at least for the time being, after a federal court Sept. 29 quashed the latest legal effort by three consumer groups to further delay implementation of the rehabilitation limit.

The decision now leaves the chance of a remedy on the $1,590 limit on outpatient physical, speech and occupational therapy, which took effect Sept. 1, up to Congress. Medicare conferees have endorsed a one-year moratorium on the caps, beginning next year, as part of the Medicare conference report lawmakers are trying to craft.

Senate Republicans on the environment panel have reached agreement on contentious chemical security legislation, and plan to move the bill through the committee in October, a GOP aide says.

"We've been working to try and get a deal for some time and think we've got it," a Senate GOP aide says. Committee Chairman James Inhofe (R-OK) appears to have reached an agreement with Sen. Lincoln Chafee (R-RI) on a provision in the bill that would address companies' uses of less toxic materials in their industrial processes.

A Pfizer official argues that increased spending on direct-to-consumer advertising, while it will increase sales of products within a drug class, does not necessarily guarantee increased sales for the specific brand-name drug advertised.

Neal Masia, assistant director for economic policy at Pfizer, spoke on the issue at FDA's Sept. 22-23 public meeting on DTC advertising. Masia said there is a negative correlation between advertising levels and volume change. Masia argued that sales were actually lower for some advertised drugs.

OSHA Administrator John Henshaw is eschewing a federal chemical investigative board's call for an enhanced process safety management (PSM) standard to address reactive chemicals, saying OSHA will instead provide guidance and outreach to industry and rely on general duty clause enforcement actions to address reactive hazards not covered by current PSM standards.

Clinical laboratories are seeking to quash a proposal in the Senate Medicare bill to impose new beneficiary cost sharing for laboratory tests, arguing labs would face high administrative costs collecting relatively minor payments and likely would have to absorb a substantial portion of unpaid bills.

The industry is seeking to wean Senate conferees away from the $18.6 billion savings generated by the proposal with arguments the proposal is unworkable. The labs have already received a positive response from some Senate Medicare conferees.