Thursday, September 20, 2007 Capitol
Hill Watch
House Approves Prescription Drug User Fee Act
Reauthorization
The House on Wednesday voted 405-7 to
approve a compromise bill (HR
3580) that would expand FDA oversight of prescription drug safety and reauthorize
the Prescription Drug User Fee Act, which expires on Sept. 30, the New York Times reports (Harris, New
York Times, 9/20). The bill is being "heralded as the most
significant drug safety legislation in more than 40 years," according to
the AP/Boston Globe (AP/Boston
Globe, 9/20).
House and Senate negotiators wrote the
legislation based on reauthorization bills (HR
2900, S 1082) that were passed earlier in the summer. The drug
safety provisions in the first House bill were "considered more
far-reaching than those in the Senate measure," and the new legislation
was crafted based on several compromises between the two versions,
according to CQ Today (Armstrong, CQ Today,
9/19).
The Senate on Thursday is expected to pass the bill, and
President Bush "will probably sign the measure quickly," according to the
Times. If the bill is not signed, FDA on Friday will have to
begin to issue dismissal notices for about 2,000 employees. Under the
legislation, the user fees that drug companies pay to FDA to speed
approval times would increase about 25% to $400 million. User fees paid by
medical device makers also would increase.
Drug Safety
The bill would give FDA the authority to require
pharmaceutical companies to conduct postmarket clinical trials on drugs
that have been approved and to impose fines on companies that fail to do
so (New York Times, 9/20).
In addition, the
legislation would establish a computerized surveillance system to try to
identify safety problems with drugs that recently have come on the market.
The system would scan insurance and pharmacy claims data to try to
identify problems, rather than relying on anecdotal reports from
physicians and drug companies, as under the current system
(Alonso-Zaldivar, Los Angeles Times, 9/20). In addition,
pharmaceutical advertisements would receive closer review by FDA, and the
ads would have to include instructions on how to report side effects
(Los Angeles Times, 9/20).
The new House bill omits
Senate language that would have required FDA approval for label changes if
the drug maker discovered a safety issue with the drug. Critics argued it
would make it "almost impossible" for consumers to sue drug makers for
withholding safety information, according to CongressDaily
(Edney, CongressDaily, 9/20). The new House bill states that
drug manufacturers have a responsibility to maintain drug labels -- "thus
leaving the manufacturers potentially liable if they fail to make changes
even without the FDA's explicit approval," according to the
Journal (Wilde Mathews, et al., Wall Street
Journal, 9/20).
The legislation also would give FDA the
authority to force drug makers to change information on product labels and
would grant it the power to limit the distribution of certain drugs
(New York Times, 9/20).
Pediatric Safety Trials
The compromise bill would grant six
months of market exclusivity to drug makers who conduct studies on new
pediatric uses of drugs. The original Senate bill would have granted three
months of exclusivity (CQ Today, 9/19).
Rep. Henry
Waxman (D-Calif.) disagreed with the provision, saying that six months of
exclusivity for blockbuster prescription drugs is excessive because drug
makers make a "windfall" profit on such medicines at the expense of
consumers (Cohen, Newark Star-Ledger, 9/20). Waxman said that
the profits that result from the period of exclusivity exceed the cost of
conducting the new studies (CQ Today, 9/19).
Conflicts of Interest
The original House and Senate bills
differed on rules governing conflicts of interest within FDA advisory
panels. The House originally called for allowing FDA to issue one
conflict-of-interest waiver per advisory panel meeting, while the Senate
wanted no limits. The compromise bill requires FDA to determine the number
of waivers granted in fiscal year 2007 and then reduce that number every
fiscal year by 5% until 2012 (CongressDaily, 9/20).
Clinical Trial Disclosure
Under the legislation, drug
companies would be required to post publicly the results of all clinical
trials pertaining to medications that already have been approved
(New York Times, 9/20). Administered by NIH, the system would be public
and searchable, and it would include information on safety risks (CQ
Today, 9/19).
Lawmaker Response
House Majority Leader Steny Hoyer (D-Md.)
said, "I hope the Senate will move forthwith to approve the bill in order
to avoid jeopardizing the jobs of the employees responsible for
implementing these critical programs" (Rockoff, Baltimore Sun, 9/20).
Waxman said,
"On a number of issues, the movement was to enlist Republicans, but I
don't think it was necessary to do what they've done." Waxman added that
he still supports the bill (CongressDaily, 9/19).
Rep. Joe Barton (R-Texas) noted, "No drug is completely safe,"
adding that the bill strives to "ensure that the balance between benefit
and risk remains in equilibrium."
Sen. Edward Kennedy (D-Mass.)
said, "This is not a perfect bill, and compromises were made to assure its
passage," but "after so many recent instances in which Americans have been
harmed by unsafe prescription drugs, ... America cannot afford inaction on
this important measure" (Los Angeles Times, 9/20).
House Energy and
Commerce Committee Chair John Dingell (D-Mich.) said, "This
legislation strikes the proper balance between new drug safety measures
and ensuring consumers have access to innovative prescription
pharmaceuticals in a timely manner" (CQ Today, 9/19).
Additional Comments
Bill Vaughan, a senior policy analyst at
Consumers Union,
said that the legislation will "save a lot of lives in the long run,"
adding, "We don't get these kinds of votes every day" (Baltimore
Sun, 9/20).
The Times notes that drug
makers "largely supported the measure, hoping that a few key concessions
... would increase public confidence in the drug agency and, by extension,
their own drugs" (New York Times, 9/20). Pfizer lobbyist Dolly
Judge said that the company believes that the bill "will increase FDA's
regulatory authority and hopefully restore people's confidence in the
agency and kind of give (FDA) a bigger hammer" (Wall Street
Journal, 9/20).
Some observers noted that the 422-page bill
is so complicated that it will take some time to digest (CQ
Today, 9/19). Peter Barton Hutt, former FDA general counsel, said,
"It's a Christmas tree with more moving parts than you can imagine"
(New York Times, 9/20).
Broadcast Coverage
CBS' "Evening News" on Wednesday reported on the bill. The
segment includes comments from Vaughan (Andrews, "Evening News," CBS,
9/19). Video of the segment is available online.