Newark
Star Ledger, Sunday, June 11, 2006
Congress
Slow to Act on FDA Reforms:
Critics Say Big Pharma Blocks Major Changes
By Robert Cohen
WASHINGTON -- The recall of popular pain medicine Vioxx because of links
to deaths and heart attacks prompted congressional hearings, harsh criticism
of the Food and Drug Administration and proposals for stronger drug safety
procedures.
Yet almost two years later, neither the House nor the Senate has taken any legislative action on drug safety, and neither is likely to do so any time soon.
"This Congress has refused to consider any of the proposals to reform the FDA, and that refusal comes about because members are comfortably obliged to the pharmaceutical industry," said Rep. Maurice Hinchey (D-N.Y.), the sponsor of one of the drug-safety bills.
"We expected more urgency and we wanted more urgency," said Diana Zuckerman of the National Research Center for Women & Families, a nonprofit public interest group. "There has been a lot of talking, but that's all."
Lawmakers and officials from consumer and industry groups predict the drug safety issue won't come to the front burner until at least a year from now, when Congress must renew the law authorizing payment of pharmaceutical company user fees to the FDA to cover the costs of drug reviews.
For the drug industry, the go-slow congressional approach is welcome.
"We have been very cautious as we have reviewed legislative initiatives over the past year," said Alan Goldhammer, an associate vice president of the Pharmaceutical Research and Manufacturers of America, the major industry trade group.
"There is a tendency to react to the news of the day, but these are all complex issues, and one doesn't want to make dramatic policy changes without a thorough examination," Goldhammer said.
During the past two years, the FDA has been criticized for its handling of Vioxx and other heavily marketed pain medications that studies have linked to deaths, heart attacks and strokes.
Merck, Whitehouse Station, pulled its Vioxx painkiller from the market in 2004, and the FDA, under close scrutiny, later ordered Pfizer to withdraw its Bextra arthritis medicine and required more warnings on pain pills.
The FDA also has been faulted for not moving quickly enough to deal with the potential link between suicidal tendencies and antidepressants in children and for failing to closely regulate direct-to-consumer drug advertising.
A Wall Street Journal Online/Harris Interactive poll released last month found only 36 percent of the public thinks the FDA is doing a good job, down from 56 percent in 2004. The poll also found that 80 percent of the public has concerns about the FDA's ability to make independent decisions to make sure patients are getting safe and effective medicines.
A year ago, Sen. Charles Grassley (R-Iowa), who held a public hearing exploring missteps by the FDA and Merck in the handling of Vioxx, introduced legislation to create an independent drug safety center within FDA.
Under his bill, if a drug turned out to have safety problems, the unit could restrict distribution, require labeling changes or even withdraw its approval. Currently, the FDA center that approves drugs also reviews safety and must negotiate recalls or labeling changes with the drug companies.
The measure would give the FDA authority to mandate that manufacturers create a registry of all clinical trials and conduct additional clinical studies if questions about safety arise after a drug is on the market. It also would impose more direct-to-consumer advertising rules.
Hinchey introduced a similar bill in the House.
Sen. Mike Enzi (R-Wyo.), chairman of the committee with jurisdiction covering the FDA, and Sen. Edward Kennedy of Massachusetts, the ranking Democrat, are drafting their own bill that will be introduced this summer.
Details aren't available, but some interest groups briefed about the legislation said it is likely to seek more transparent and complete dissemination of pre-market clinical trial data, and better FDA oversight procedures once a drug has been approved for use.
The bill, however, isn't expected to recommend creation of a powerful drug safety center within the FDA.
Hoping to head off congressional action, the FDA last year created a board inside the agency to oversee management of drug safety issues.
But in April, the Government Accountability Office, the congressional investigating agency, said the FDA still lacks a reliable system for keeping track of emerging drug safety problems.
The GAO concluded the oversight of safety was still marred by poor information, a lack of legal authority to order companies to restudy drugs once they are on the market, and disagreements between the FDA bureau that approves drugs and the smaller safety board.
The pharmaceutical industry, while defending its practices and opposing any major changes at the FDA, has adopted added voluntary guidelines for direct-to-consumers advertisements of prescription drugs. And Bristol-Myers Squibb imposed a ban on advertising its drugs to consumers during their first year on the market.
Henry Miller, the founding director of the FDA's Office of Biotechnology and now a fellow at Stanford University's Hoover Institution, is among those who believe criticism of the FDA has been counterproductive, making the agency "more risk adverse" and adding costs and delays in getting medicines to market.
But William Vaughan, a senior policy analyst for Consumers Union, said it is important to keep the spotlight on the FDA.
"We need to solve weaknesses in the FDA that have caused tens of thousands of people to die needlessly or prematurely because of drugs inadequately tested and too aggressively advertised," Vaughan said. "I wish stronger legislation could be enacted this week, but because of resistance from the pharmaceutical industry, it is likely to take at least a year."
Yet almost two years later, neither the House nor the Senate has taken any legislative action on drug safety, and neither is likely to do so any time soon.
"This Congress has refused to consider any of the proposals to reform the FDA, and that refusal comes about because members are comfortably obliged to the pharmaceutical industry," said Rep. Maurice Hinchey (D-N.Y.), the sponsor of one of the drug-safety bills.
"We expected more urgency and we wanted more urgency," said Diana Zuckerman of the National Research Center for Women & Families, a nonprofit public interest group. "There has been a lot of talking, but that's all."
Lawmakers and officials from consumer and industry groups predict the drug safety issue won't come to the front burner until at least a year from now, when Congress must renew the law authorizing payment of pharmaceutical company user fees to the FDA to cover the costs of drug reviews.
For the drug industry, the go-slow congressional approach is welcome.
"We have been very cautious as we have reviewed legislative initiatives over the past year," said Alan Goldhammer, an associate vice president of the Pharmaceutical Research and Manufacturers of America, the major industry trade group.
"There is a tendency to react to the news of the day, but these are all complex issues, and one doesn't want to make dramatic policy changes without a thorough examination," Goldhammer said.
During the past two years, the FDA has been criticized for its handling of Vioxx and other heavily marketed pain medications that studies have linked to deaths, heart attacks and strokes.
Merck, Whitehouse Station, pulled its Vioxx painkiller from the market in 2004, and the FDA, under close scrutiny, later ordered Pfizer to withdraw its Bextra arthritis medicine and required more warnings on pain pills.
The FDA also has been faulted for not moving quickly enough to deal with the potential link between suicidal tendencies and antidepressants in children and for failing to closely regulate direct-to-consumer drug advertising.
A Wall Street Journal Online/Harris Interactive poll released last month found only 36 percent of the public thinks the FDA is doing a good job, down from 56 percent in 2004. The poll also found that 80 percent of the public has concerns about the FDA's ability to make independent decisions to make sure patients are getting safe and effective medicines.
A year ago, Sen. Charles Grassley (R-Iowa), who held a public hearing exploring missteps by the FDA and Merck in the handling of Vioxx, introduced legislation to create an independent drug safety center within FDA.
Under his bill, if a drug turned out to have safety problems, the unit could restrict distribution, require labeling changes or even withdraw its approval. Currently, the FDA center that approves drugs also reviews safety and must negotiate recalls or labeling changes with the drug companies.
The measure would give the FDA authority to mandate that manufacturers create a registry of all clinical trials and conduct additional clinical studies if questions about safety arise after a drug is on the market. It also would impose more direct-to-consumer advertising rules.
Hinchey introduced a similar bill in the House.
Sen. Mike Enzi (R-Wyo.), chairman of the committee with jurisdiction covering the FDA, and Sen. Edward Kennedy of Massachusetts, the ranking Democrat, are drafting their own bill that will be introduced this summer.
Details aren't available, but some interest groups briefed about the legislation said it is likely to seek more transparent and complete dissemination of pre-market clinical trial data, and better FDA oversight procedures once a drug has been approved for use.
The bill, however, isn't expected to recommend creation of a powerful drug safety center within the FDA.
Hoping to head off congressional action, the FDA last year created a board inside the agency to oversee management of drug safety issues.
But in April, the Government Accountability Office, the congressional investigating agency, said the FDA still lacks a reliable system for keeping track of emerging drug safety problems.
The GAO concluded the oversight of safety was still marred by poor information, a lack of legal authority to order companies to restudy drugs once they are on the market, and disagreements between the FDA bureau that approves drugs and the smaller safety board.
The pharmaceutical industry, while defending its practices and opposing any major changes at the FDA, has adopted added voluntary guidelines for direct-to-consumers advertisements of prescription drugs. And Bristol-Myers Squibb imposed a ban on advertising its drugs to consumers during their first year on the market.
Henry Miller, the founding director of the FDA's Office of Biotechnology and now a fellow at Stanford University's Hoover Institution, is among those who believe criticism of the FDA has been counterproductive, making the agency "more risk adverse" and adding costs and delays in getting medicines to market.
But William Vaughan, a senior policy analyst for Consumers Union, said it is important to keep the spotlight on the FDA.
"We need to solve weaknesses in the FDA that have caused tens of thousands of people to die needlessly or prematurely because of drugs inadequately tested and too aggressively advertised," Vaughan said. "I wish stronger legislation could be enacted this week, but because of resistance from the pharmaceutical industry, it is likely to take at least a year."