FDA bill trimmed to ease passage

Democrats are displaying their willingness to compromise with Republicans by stripping provisions opposed by GOP lawmakers from a Food and Drug Administration reauthorization bill. The concessions pave an easy path for passage as the House legislation is now more in line with its companion bill that overwhelmingly passed the Senate last month.

Members of the House Energy and Commerce health subcommittee approved a watered-down legislative package granting the FDA new authority to regulate prescription drugs after the products go on the market, as well as renewing programs that allow the FDA to charge fees to drug and medical-device companies to help fund the agency.

The issue of how much money the FDA can collect from drug makers is still in play in the House bill. Republicans are continuing an effort to undercut proposed funding that the House set at $225 million. The Senate bill calls for only $50 million in fees from drug makers, while the FDA proposed collecting $338 million.

The legislation was being considered by the full Energy and Commerce Committee late yesterday.

Democrats on the subcommittee already accommodated Republicans by pulling out elements of the bill that would have given the FDA power to place a three-year moratorium on direct-to-consumer advertisements for new drugs that the agency deemed misleading. Under the amended version, which is similar to the Senate’s bill, the agency can fine a drug company $250,000 for false advertising; preview ads and recommend changes to the drug company; and require disclosures in the ads.

“The makers of Vioxx made more than $4 million a day in sales from heavily advertising their drugs to everyone with arthritis pain, even though there was the potential for serious heart risks from taking it,” said Bill Vaughn, senior policy analyst for Consumers Union. “Hitting a company with a fine of only $250,000 for running ads that don’t talk about all the risks won’t change anything.”

But despite the weakened drug-enforcement language in the bills, Democrats’ actions are viewed as a legitimate compromise in order to get legislation that is palatable in the Senate and that President Bush will sign into law.

“I think that getting a consensus agreement was of overreaching importance and it was easier to tip to the Republicans and maybe not give [California Democratic Rep. Henry A.] Waxman and [Massachusetts Democratic Rep. Edward J.] Markey everything they wanted to get something that could get universal support,” said an Energy and Commerce staffer.

Also gone from the House bills is “federal pre-emption” language that was anathema to Republicans and may have ultimately derailed the bill. The pre-emption language stated that strict compliance with FDA regulations would not protect pharmaceutical companies from product liability lawsuits filed in state courts. But the language was much ado about nothing, according to some monitoring the bill.

“To have a bloody fight over whether lawyers could point to this new law as proof that Congress pre-empts the states, when there is clearly no pre-emption language as there is with medical devices is just not worth the bad will,” said a close observer of the bill. “I think they are trying to get a bill like the Senate’s with a lot of Republican support, and this issue was just not important the way it was drafted.”

c Health Care runs on Fridays. Contact Gregory Lopes at 202/663-4892 or glopes@washingtontimes.com.