The Association of U S West Retirees



Drug Industry Faces Bitter Pill

Congress Proposes

Tougher Regulation, Cheaper Medications


February 2, 2007; Page A6

Wall Street Journal


Congress is kicking off efforts to pass big reforms of the Food and Drug Administration, and that could produce some bitter pills for the pharmaceutical industry: potentially, tougher safety rules and provisions to reduce the cost of medicines.


Yesterday, Sen. Edward Kennedy of Massachusetts and Sen. Michael Enzi of Wyoming, the chairman and ranking Republican of the health committee, respectively, introduced legislation that would give the FDA new authority to impose safety requirements on medicines once they go on the market, including restrictions on consumer advertising. The bill also would require registration of clinical drug trials and their results in public databases.



Meanwhile, Sen. Chris Dodd of Connecticut, a Democrat, and Sen. Charles Grassley of Iowa, a Republican, on Wednesday introduced their own drug-safety bills, which would restructure the FDA to create a center to oversee the safety of drugs after they go on the market.


Proposals to beef up regulation have stalled before, often due to skepticism from Republican allies of the industry. This year is likely to be different.

Democrats aren't reluctant to give expanded authority to federal regulators and see the drug industry as a tempting target because of its tenuous popularity with consumers and its traditional ties to Republicans. And they're getting support from some Republicans upset by a series of high-profile drug-safety problems, including the 2004 withdrawal of the painkiller Vioxx.


Also, lawmakers have a ready-made vehicle for the changes: legislation that must be approved this year to renew the deal under which the industry pays fees to fund much of the FDA's drug-review process. The current user-fee agreement expires later this year.


"It's pretty clear we have drug-safety problems, and it's clear we need to address those matters," says Rep. John Dingell (D., Mich.), chairman of the House Energy and Commerce Committee, which has jurisdiction over the FDA.

Several lawmakers say the agency's latest drug-safety initiatives, announced Tuesday, need to be bolstered with new legislation.


While these bills are now stand-alone measures, many on Capitol Hill expect that whatever safety legislation moves forward will be combined with the user-fee bill. That legislation also might end up linked to proposals to create a pathway for FDA approval of generic versions of biotech drugs -- which proponents argue would rein in the cost of such medicines -- and allow imports of medication from overseas. Both provisions are opposed by the drug industry, which is pressing for a "clean" user-fee bill.





  What's New: Members of Congress propose to increase the FDA's drug-safety oversight and create a path for the agency to approve generic biotech drugs.


  The Issue: The drug industry is concerned about the effect of such legislation.


  What's Next: Proposals to change the FDA may be included in legislation authorizing fees that fund many agency operations.


"We're concerned that it not become a Christmas tree," loaded with legislative extras, says Billy Tauzin, chief executive of the Pharmaceutical Research and Manufacturers of America, the industry's main lobbying group.

But, he says, "we appreciate that the odds are that people are going to load it up."


In an effort to defuse controversial issues and lay the foundation for the user-fee bill, the pharmaceutical industry and the FDA struck a deal, unveiled a few weeks ago, that would provide the agency with $393 million in industry user fees for the next fiscal year. That is an increase of about one-third from the current year.


The pact would grant the FDA substantially more money for safety monitoring, and fund more staff to review pharmaceutical ads. That dovetails with voluntary campaigns by companies to submit their ads to the FDA and include their studies in public registries.


Mr. Tauzin says the industry "has real concerns" about what the Kennedy-Enzi bill might do, and opposes Sens. Grassley and Dodd's proposal to create an FDA drug-safety center: "Is this needed legislation, or is it going to create some new authorities that are problematic?"


If Congress doesn't pass the FDA fee legislation by late summer, it risks shutting down much of the agency's drug-regulation activity. Complicating matters, other FDA-related laws also must be renewed this year, including the fees that fund the agency's regulation of medical devices.


Mr. Dingell says he doesn't want to "bog down" the user-fee bill with procedural fights over provisions that aren't germane, but he also wants to step up drug safety. Later this month, his committee is expected to hold a hearing on drug safety that will include Sen. Grassley, an exacting FDA watchdog. Mr. Dingell calls the proposal to create a drug-safety center at the FDA an "intriguing idea," but says he wants to learn more before endorsing a plan.


Another focus for Congress: drug ads. Mr. Dingell says his reservations about such consumer advertising "have only grown with the passage of time."

Democratic Rep. Frank Pallone of New Jersey, chairman of the Energy and Commerce health subcommittee, says the issue "could be part of the reauthorization" of the fee bill, but leaders will "see where there's a consensus" before deciding.


Another House Democrat, Henry Waxman of California, says he plans a drug-safety bill that will largely mirror the Kennedy-Enzi proposal. "The FDA does not have the authority it should have and that our legislation would give them," he says.


The Kennedy-Enzi bill would strengthen the FDA's oversight of drugs after they go on the market, by requiring that drugs be approved with programs to manage their risks. Those programs might be very limited, but they could also include an array of provisions the FDA doesn't currently have the explicit power to impose, including mandatory safety studies, restrictions on who can prescribe or dispense a drug, and an initial ban on consumer ads.

A Kennedy staffer says that while the bill initially will be separate from user-fee legislation, "we imagine the process is one where all of these things end up being joined at some point."


The biggest concern for the biotech industry is legislation planned by Mr.

Waxman, which would create a path for generic versions of biotech drugs.

Sen. Hillary Clinton (D., N.Y.), a member of the health committee, plans to tie that effort to the user-fee legislation. "Linking it to [the user-fee bill] would be a good idea, because that's must-pass legislation," says another New York Democrat, Sen. Charles Schumer, who will be the generic biotech bill's lead Senate sponsor.


James Greenwood, chief executive of the Biotechnology Industry Organization, says the issue is too complex and scientifically delicate to be examined and resolved in time to link it to the user-fee legislation. "There's barely enough time to have the members of the House and the Senate understand what's in the [user-fee bill]," he says.


Write to Anna Wilde Mathews at