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House proposal major victory for drug safety

Thursday, June 7, 2007

Proposed House Drug Safety Legislation is Major Victory for Patient Safety, Public Trust, Consumers Union says

Bill builds and improves on Senate measure; hearing slated for Tuesday

(Washington, D.C.) – A proposed prescription drug safety bill released today by a House panel is a “major victory” for patient safety, and builds on legislation passed in the Senate by including stronger limits on advertising of unsafe drugs, ensuring clinical drug trial results are made public, and limiting conflicts-of-interest on drug advisory committees.
“Chairman Pallone’s discussion draft is a major victory for consumers, and is a huge step forward in improving prescription drug safety,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. “All the House members who have worked on this bill are to be congratulated. This proposal helps ensure consumers have more information about drug risks, so all of us can make better informed health-care decisions.”
The legislative draft from Rep. Pallone, chairman of the House Energy and Commerce Health subcommittee, is expected to be discussed at a hearing Tuesday, June 12. Consumers Union President Jim Guest is slated to be among those testifying on the legislation.
The House proposal includes many of the Senate features, including $225 million more in drug industry user fees to help pay for drug safety, and the active monitoring of huge medical databases to detect safety problems. “If such a monitoring system had been in place years ago, the whole Avandia controversy may well have been resolved years earlier,” Vaughan said. “The diabetic community would have had answers on the safety of this drug within a year or two, rather than drifting for eight years.”
The House proposal goes further than the Senate bill by requiring all new drugs display a symbol that they are new to the market; that all new drugs go through a risk evaluation process that can include limiting of direct-to-consumer ads for those drugs with severe and unusual safety issues; and granting only one conflict-of-interest waiver per drug advisory committee.
The House measure also sets out guidelines for how the drug industry must register and report their clinical drug trials to make them publicly accessible. The Senate bill calls for a 30-month study and rulemaking for those trial results guidelines, and it is unclear how comprehensive the final proposal will be.
“The House has the opportunity to pass real reforms that will give the FDA the power to act quickly and decisively when drug safety problems arise,” Vaughan said. “This proposal should help put an end to incidents like Vioxx, where the public was kept in the dark about possible health risks.”
Consumers Union hopes to work with the House members to improve the scientific integrity, right to dissent, transparency, and influence of the FDA drug safety office under the House proposal. A survey of FDA scientists by the Union of Concerned Scientists last year found that many felt that safety recommendations and proposals were given short shrift by the agency.
The House bill also gives the FDA the authority to impose tough fines on drug companies that fail to comply with safety measures, such as performing post-market studies or posting clinical trial results. Rather than a set fine, the House measure calls for a drug maker to pay a percentage of the drug’s profits for not complying with law.
“Tougher fines on drug companies will finally give the FDA the power to get these companies attention on drug safety,” Vaughan said. “Fines shouldn’t be just a cost of doing business, they should have an impact so the industry will want to comply with drug safety measures.”
The House proposal also calls for including consumer and patient advocates to participate in negotiations between the drug industry and the FDA on the next user fee proposal, slated for 2012. Currently, the FDA and pharma negotiate behind closed doors on how much the industry will pay to expedite the drug approval process, and what the FDA will do in return. These user fees, known as the Prescription Drug User Fee Act, are up for reauthorization this year and are renegotiated every five years.
“By making dealings between the FDA and the drug industry more transparent, the House bill is helping restore public trust in the process,” Vaughan said. “It’s a great addition to have patients and consumers involved in those negotiations, since they are the people directly affected.”
Susan Herold, Bill Vaughan, 202-462-6262