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By ROSALIE WESTENSKOW
UPI Correspondent
WASHINGTON, May. 9 (UPI) -- On the heels of the Senate's passage Wednesday of a bill bolstering the power of the Food and Drug Administration to regulate drugs, lawmakers continued debate at a House hearing on how to fix what some say is an inefficient and lackadaisical agency.
And as with the just-passed senate bill -- The Enhancing Drug Safety and Innovation Act of 2007 -- House lawmakers are particularly focused on upping safety after drugs have hit the market and are being prescribed to thousands of patients.
The issue of drug safety has intensified in recent years, fueled by a number of incidents that put the FDA in a negative light, including the September 2004 recall of Vioxx, an arthritis drug that increased the risk of heart attacks when used long term.
Lawmakers raised a variety of concerns about the FDA's practices at the hearing, including the agency's ability to regulate drugs after their introduction to the market.
"I have publicly expressed my dissatisfaction with the way in which the FDA has handled the important issue of drug safety," said Rep. John Dingell, D-Mich. "The FDA must ensure that just as much time, resources and energy are invested in aggressive post-market observation as is spent in pre-market trials, consultation and meetings with industry."
In general, the agency cannot currently require pharmaceutical companies to complete post-market clinical trials studying a specific safety concern raised after the drug's release. As a result, many suggested post-market trials are never completed.
"One study estimated the completion rate of post-market studies ... rose from 17 percent in the mid-1980s to 24 percent between 1991 and 2003," according to a statement submitted by Marcia Crosse, director of healthcare for the Government Accountability Office.
Because it lacks the political muscle to compel the completion of post-market studies, the agency often relies on negotiation with the drug's maker.
For now, if a company refuses to cooperate in doing follow-up studies, the FDA sometimes opts to disseminate its concerns about a drug directly to the public, said Steven Galson, director of the Center for Drug Evaluation and Research, the FDA division that oversees new prescription drugs.
"Once we say we're going to go out and put this information in the public market, (pharmaceutical companies) usually move," he said.
However, many lawmakers said they think the agency needs to be granted additional funding and greater authority over drug companies. The Enhancing Drug Safety and Innovation Act, awaiting debate in the House, addresses these concerns.
The bill's passage would help prevent drug-safety disasters, said Lisa Van Syckel, a representative of Families Hurt by Unsafe Drugs. Van Syckel's daughter, Michelle, was prescribed the antidepressant Paxil when she was 14 and within weeks began demonstrating suicidal and self-mutilation tendencies. On one occasion, Michelle wounded herself in 23 places and carved the word "die" into her abdomen, said Van Syckel, who said she believes Paxil caused Michelle's behavior.
"Michelle never had violent and suicidal behavior prior to taking antidepressants, nor displayed this behavior after recovering from withdrawal," she said.
Van Syckel, who was given little information about her daughter's treatment, said the FDA has failed to adequately inform the public of risks associated with various pharmaceuticals. Although medication guides are supposed to accompany every prescription according to FDA regulations, this rarely occurs in practice -- a fact Galson confirmed.
"If your children are on medications, download a medication guide (on the Internet) and monitor your children," Van Syckel told United Press International.
Counterfeit drugs represent another threat to consumer safety and have increased in recent years, said John Theriault, chief security officer for Pfizer.
"During 2006, authorities from 36 countries reported seizing more than 8.1 million counterfeit tablets, a 20.8 percent increase over 2005," he said.
The problem is widespread and deadly. Just last fall Panamanian authorities linked 365 deaths to poisonous cough syrup imported from a manufacturer in China.
Fake drugs are often sold to unwitting customers over the Internet through Web sites falsely identified as Canadian pharmaceutical companies.
Low penalties make the counterfeit-drug market a lucrative trade, and Rep. Joe Barton, R-Texas, said stricter punishments must be imposed in order to curb the prevalence of phony drugs.
"It is shocking and unacceptable that the maximum penalty for counterfeiting a prescription drug in this country is three years in prison," Barton said. "Intentionally giving a seriously ill person a drug that does not contain an active ingredient that they think it does could actually be considered to be murder."
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