A Medical Device Daily

Lester Crawford, former head of the FDA, was sentenced yesterday to three years of probation and a fine of $90,000 despite pleading guilty to conflict of interest charges. That nearly doubled the prosecutor's recommendation of a fine of $50,000 (Medical Device Daily, Jan. 26, 2007).

Crawford resigned from the FDA post in 2005 after holding the job for only about two months and thus raising suspicions. And he subsequently pleaded guilty to charges of conflict of interest and filing seven false reports of stocks held by him and his wife.

Magistrate Judge Deborah Robinson of the U.S. District Court for the District of Columbia acknowledged that while the imposed fine "exceeds what the parties agreed to, the fine is well below the maximum under the statute."

Robinson reportedly questioned the sincerity of Crawford's remorse during the 90-minute hearing, adding a community service requirement of 50 hours as well as responsibility for paying for the cost of the supervised probation.

Both the charges are deemed misdemeanors and carry maximum fines of $100,000.

"I want to assure you that I accept responsibility for what I've done," Crawford told Robinson during the hearing, adding that "I should have communicated better with the people helping me" on the financial reports, which were filed with Congress and a government ethics office.

After being confirmed by the FDA to its top post, Crawford then left after two months, citing his advanced age as an excuse. His resignation left the agency without a formally designated head until the confirmation of Andrew von Eschenbach in December.

Baxter gets nod for Colleague from FDA

After lengthy work to provide fixes for a number of problems with its Colleague line of infusion pumps, Baxter Healthcare (Deerfield Park, Illinois) has finally won a new 510(k) clearance from FDA to bring the pumps back to market.

The agency issued a recall and seized a number of the pumps in July 2005 after the units exhibited problems with displays and batteries that swelled, leading to a potentially lethal shutdown of the pumps. At the time, Baxter had taken in six reports of serious injury and three of death that were associated with the problem.

The agency gave the company conditional approval of its corrections in December, and those changes gave rise to the resubmission of 510(k) paperwork.

In a statement posted on the firm's web site, Robert Parkinson, Jr., CEO of Baxter, said that getting the Colleague back to market "reflects our commitment to resolving reliability and user interface issues associated with these critical devices and restoring our customers' confidence by delivering high quality, innovative infusion technologies." Parkinson also expressed appreciation for "our customers' patience as we've worked to resolve these issues"

Baxter had sold slightly more than a quarter of a million Colleague pumps by the time of the recall. It said that the design problem stemmed from "a clocking circuit contained in the pump that can disrupt internal communications in some devices."

The failure was serious enough that Baxter included in its recall announcement the recommendation that "you should consider not using these pumps in situations where a replacement pump is not available or where a delay in therapy may be life threatening."

At press time yesterday, Baxter's shares on the New York Stock Exchange had risen $.65 to $49.75 on a volume of almost 1.78 million shares.

Mandatory employer insurance job-costly

Economic forecasting is probably as dicey an undertaking as predicting the weather, but that doesn't stop anyone, professional or amateur, from trying their hand at it.

In a study sure to find fans in the legions of small and medium businesses in the U.S., the Employment Policies Institute (EPI; Washington) has issued a report concluding that a mandate on businesses to provide employees with health insurance would drive almost 995,000 Americans out of work.

The study, conducted by economists Ellen Meara, PhD, an assistant professor of health economics in the Department of Health Care Policy at Harvard Medical School (Boston) and Meredith Rosenthal, PhD, an associate professor of health economics in the same office, concluded that such a mandate might increase the numbers of unemployed by more than 8 million while forcing about 1.6 million into part-time from full-time work. The impact on aggregate wages is projected at $71 billion.

Jill Jenkins, chief economist at EPI, said that "[t]he sizable job losses and hour reductions that accompany employer mandates should give legislators pause." However, despite the recommendation of expanding Medicaid, included in the report, Jenkins also said that "[r]ather than arguing about who should pay for insurance, policymakers should start arguing about how to lower the cost of healthcare."

According to the study, expanding Medicaid coverage to 300% of the federal poverty level would boost the number of insured adults by 5 million and of uninsured children by nearly 600,000. The study also projected a shift of 57,000 employees from part-time to full-time employment, and cost Uncle Sam and state governments $16.4 billion while increasing aggregate wages by a similar amount, $16.5 billion.

In comparison, offering a tax credit of $1,000 for each adult and half that amount for everyone younger than 18 would cost almost $20 billion in state and federal taxes and would increase coverage by only 1.6 million "at a cost of $12,644 per person," according to the report.

According to the Agency for Healthcare Research and Quality (Washington), the per-person cost of healthcare in the U.S. in 2004 was $6,280.