Washington Editor

WASHINGTON - Fresh off a plane from Afghanistan, Health and Human Services Secretary Tommy Thompson's first stop Thursday was the FDA's annual Science Forum, where he brought the crowd up to speed on a few administration proposals related to FDA issues.

With a bit of a cold and the flu - and possibly some jet lag - Thompson told the 1,800 attendees of his experience opening an improved and refurbished Rabia Balkhi Women's Hospital in Kabul. He said he was struck by the living conditions and poor public health infrastructure in Afghanistan, and that he was thankful to live in the United States, where the health care is the best in the world. "People don't leave America to get treatments, they come to America for treatment," he said.

Nevertheless, there's always room for improvement.

And speaking of hospitals in Third World countries, Thompson said hospitals in the U.S. could use a little assistance in cutting down on the dreaded medical error. By now, nearly everyone in the industry has heard of that famous report, "To Err is Human: Building a Safer Health System," which said upward of 100,000 people die every year in U.S. hospitals due to preventable medical errors, often related to drugs.

The report fueled the FDA's mission to look for ways of reducing some of the senseless errors that occur in hospitals and even in pharmacy situations. So, about a year ago, the agency floated the idea of mandating bar codes on prescription drugs and biologics, vaccines and certain over-the-counter drugs. At minimum, the code would contain the product's National Drug Code, a number that identifies each drug, its dosage form and strength. Medical devices were not included in the rule.

"I've always said that grocery stores are more technologically advanced than we are sometimes in the health care field," Thompson said. "You go into a grocery store and a kid under 18 scans your groceries - he can't make an error because the computer prevents him from it."

The bar-coding regulation was published in March as a proposed rule with a 90-day comment period, set to expire in June. (See BioWorld Today, March 21, 2003.)

Meanwhile, the agency is looking at strengthening its requirement on reporting medical errors and adverse events.

And regarding drug development, Thompson touched on the issue of protecting Americans against chemical or biological weapons. President Bush's plan for action is referred to as Project BioShield, and it's designed to speed development and availability of medical countermeasures in response to the current threats.

Both Thompson and Mark McClellan, FDA commissioner, have been on Capitol Hill in recent weeks doing their best to lobby support for the proposal.

In a nutshell, the proposal would streamline government research, create incentives for companies and give the government the ability to make products widely available in a public emergency.

While a couple of elements of the plan cause particular concern, many lawmakers are queasy over the section that gives the administration "mandatory" funding as opposed to "discretionary" funding. Essentially, many feel Bush is asking for a blank check to fund drug development. (See BioWorld Today, April 7, 2003, and March 28, 2003.)

In answer to that charge, Thompson and McClellan previously said mandatory funding is necessary to entice drug companies to take on the research and to guarantee a market.

In his remarks Thursday, Thompson again said drug companies need incentives to enter the countermeasure business. "The currently available antitoxin for botulism is based on technology from 1906 - the same year the FDA was created," he said. "There's got to be something better out there."

And then there's the issue of prescription drugs for senior citizens. Domestic problems don't seem to be as newsworthy as they once were, but Thompson said reforms for Medicare and Medicaid are being considered.

On prescription drugs, anyone who's kept up with the debate understands numerous proposals have been floated, approved, rejected and shelved.

In January, the 108th Congress started with a clean slate, meaning any legislation that hadn't received Bush's signature died. So, it was back to the drawing board on prescription drugs.

A couple of hearings have been held this year, but so far, nothing to speak of has happened.

During a recent meeting of the House Energy and Commerce Committee, Chairman Billy Tauzin (R-La.) said the Bush administration has expressed great interest in working with Congress to pass this year a prescription drug benefit for Medicare beneficiaries. "They have described a series of broad principles that they would like to pursue in designing a new benefit," Tauzin said. "While these principles differ in some ways from the approach previously passed by the House, I think they should be applauded for their efforts. They are very serious about solving this problem this year."

As he's done in the past, Tauzin pointed out that the Senate has been unable to reach a compromise on prescription drugs, unlike the House, which passed a plan last summer (H.R. 4956).

Tauzin said the House legislation would have provided "substantial assistance to all Medicare beneficiaries, covering a large percentage of their initial drug costs."

It would have helped seniors reduce costs by using private, market-based drug benefit managers, he said. (See BioWorld Today, June 24, 2002, and June 21, 2002.)