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FDA’s Ex-Chief Counsel Knocks Timing of Critical Report on Prescription Labeling Rules

October 31, 2008

On Wednesday, the House Oversight and Government Reform Committee released a report showing that at least two top FDA officials objected to making changes to federal rules regarding labeling for prescription drugs. The changes, made in 2006, created a new labeling system, with the most important warnings for doctors placed in a “highlights” section at the top of a label’s first page.

 

The new rules also banned drug companies from adding warnings to “highlights” sections without prior FDA approval — a move that critics claim was aimed at pre-empting lawsuits against drug companies. The report from U.S. Rep. Henry A. Waxman, D-Calif., who is chairman of the committee, suggests FDA officials made the changes to follow a Bush administration policy of protecting drug companies.

 

The report’s release comes as the U.S. Supreme Court is set to hear arguments Monday in the landmark Wyeth v. Levine pre-emption case.

Sheldon Bradshaw, now a partner at Hunton & Williams, oversaw the labeling-regulation overhaul in question during his stint as the FDA’s chief counsel from 2005-2007. He chatted about the House report and other issues with The Am Law Daily.

 

Read Article: Law.com

 

Concrete-Testing Firm Is Accused of Skipping Tests

Concrete that was poured at more than 100 construction projects around the city, including the Freedom Tower, the new Yankee Stadium and the Jet Blue Terminal at Kennedy Airport, over the past decade has been or will be re-examined because a testing company did not do its job, state prosecutors said on Thursday.

 

All of the structures are believed to be safe, several city officials said, although they might deteriorate sooner than expected if the concrete is below standards.

 

The testing company, Testwell Laboratories, the city’s leading concrete-testing firm, and several of its officials were indicted on Thursday on charges that they failed to perform strength tests and billed clients, including a number of public agencies, for work that was never performed.

 

Read Article: New York Times

 

Bill collectors get tough, and complaints surge

After several years in which Americans were buying stuff on credit they couldn’t afford, a rapidly increasing number are complaining about getting harassed and abused by bill collectors.

 

Nearly 71,000 people filed such complaints with the Federal Trade Commission last year, roughly double the number in 2003. In addition, more than 14,000 complained to the Better Business Bureau. Thousands more lodged grievances with state and city officials.

“And it is going to get worse,” warned David Polino, a Better Business Bureau expert on collection agencies and president of the BBB chapter in upstate New York. “With the recession, with the horrible credit problems, this is going to be off the charts.”

 

Regulators and consumer groups say the rise in complaints reflects the rapidly increasing number of Americans who took on more debt than they could handle during the free-spending, easy-credit days that preceded the current economic crisis. The complaints are also being attributed to the explosive growth in the number of companies that buy up bad consumer debt at a discount and try to collect whatever they can.

 

Read Article: Las Vegas Sun

 

Employment Attorneys’ Halloween Advice: Beware Tarzan, Togas and Naughty Nurses

The costume police are out.

With Halloween just around the corner, labor and employment attorneys are warning employers that the annual holiday could get scary — in a legal way — if costumes, or a work party, get out of hand.

 

Specifically, costumes that carry a political or social message, or are simply too raunchy for the workplace, could lead to a liability nightmare down the road.

“A naughty nurse can get you into trouble,” warned attorney Steve Miller of the Chicago office of Atlanta’s Fisher & Phillips, noting that certain costumes can set the stage for future harassment. “When you got the mix of alcohol, and somebody wearing a revealing costume, you run that risk of someone making a lewd comment.”

Other costumes that scream liability?

 

A French maid, kittens, men in togas, male Tarzans and construction workers — all of these costumes are likely to trigger sex talk, Miller said. And if the comments continue in the future, that could trigger a harassment complaint.

 

Read Article: Law.com

 

Fla. ruling will help widow’s anthrax lawsuit

A Florida Supreme Court ruling issued Thursday will help the widow of an anthrax victim make her case that the government was ultimately responsible for her husband’s death.

 

Maureen Stevens’ husband, Robert, was a photo editor who was exposed to anthrax mailed to the Boca Raton office of American Media Inc., a supermarket tabloid publisher, in 2001. He was the first of five people killed and 17 others sickened in a series of similar attacks.

 

Justices ruled 4-1 that the defendants had a duty under Florida law to protect the public against the unauthorized release of lethal materials. It’s an important, although preliminary, victory for the widow whose $50 million federal lawsuit also alleges the government and Battelle Memorial Institute, a private laboratory in Columbus, Ohio, were the source of the anthrax.

 

Read Article: Miami Herald

 

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