Medical Device Daily Washington Editor

WASHINGTON – Though Medicare’s overhauled prescription drug benefit isn’t slated for rollout until January, President George Bush began stumping for the program yesterday afternoon.

The president joined Mike Leavitt, secretary of the U.S. Department of Health and Human Services (HHS; Washington), and Mark McClellan, administrator of the Centers for Medicare & Medicaid Services (CMS; Bethesda), at HHS headquarters to launch the Medicare Covers America Tour.

The tour begins the Bush administration’s push to get seniors to sign up for the program. Early numbers of enrolled seniors so far have been fewer than CMS predicted. Problems with the current temporary program to provide discounts with a prescription drug card have plagued CMS and the administration, and many seniors find the program confusing.

The president goes to a similar event in Minnesota today.

“We passed a good law, now it is important for people to get the news,” the president said, referencing the Medicare Modernization Act passed in 2003. “Medicare recipients have been left with care based on the medicine of the 1960s.”

Bush promised “greater peace of mind” for beneficiaries under the program, including coverage plan choices and a guarantee to cover 95% of all prescription drug costs after a senior has spent $3,600 in one year on prescription drugs.

“Our outdated system made no sense for American seniors and made no sense for American taxpayers,” the president said. “This great and trusted program is going to get even better.”

McClellan has said the agency learned from its mistakes with the drug cards, and the administration would be seeking help from other parts of the government and from outside groups to encourage the elderly to enroll in the new program.

In Congress, the Medicare Modernization Act has been controversial on both sides of the aisle, especially the cost.

New projections released earlier in the year put the new drug benefit program at $724 billion over 10 years, beginning in 2006. The White House originally told Congress the cost for 2004-2013 would be roughly $400 billion. The administration and CMS have not released any further adjusted cost estimates.

FDA tries to keep adverse event reporting simple

The FDA released clarified reporting regulations governing reporting of deaths, serious injuries and certain malfunctions related to medical devices. Originally published in the Federal Register in February this year, and following a comment period, the updated regulations go into effect in July.

The agency said it is not altering guidelines in as much as it is rewriting them “into plain language in order to make regulations easier to understand.” Some technical corrections also were made, FDA said.

In summary, device user facilities must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit annual reports.

Manufacturers and importers must report deaths and serious injuries that may have caused or contributed to, must report certain device malfunctions, and must establish and maintain adverse event files.

The rule also mandates that manufacturers submit specified follow-up reports, and distributors must maintain records of incidents but are not required to report them.

The “plain language” requirement is the result of a presidential memorandum in 1998 that directed the agency to ensure that all of its documents are clear and easy to read.

The FDA said it has tried to achieve that goal by using “clear and simple language rather than jargon, by keeping sentences short, and by using active voice rather than passive voice whenever possible.”