FDA: KESSLER SPEAKS ON REFORM, TOBACCO
In an interview with USA WEEKEND, Food and DrugThis is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
Administration (FDA) Commissioner David Kessler discussed several
important issues facing the agency, including congressional FDA
reform legislation and the proposed regulation of tobacco
FDA REFORM: When asked about the four FDA reform bills now
being considered by Congress, Kessler responded that lowering FDA
standards "would be gambling with the public health." Noting
that the U.S. currently has "the highest standards in the world"
for drug approval, he said, "When a drug is approved here it
becomes an international blockbuster almost overnight. Because
it does what it says on the label." He added, "We can have it
both ways: We can be fast when we need to be for breakthrough
drugs. And we can be thorough." Kessler added that he is
"opposed" to FDA reform legislation that would mandate a six-
month approval time for all drugs, saying that 12-month approvals
for standard drugs and six months for breakthrough drugs are
"about as far as we can go safely."
TOBACCO REGULATION: When asked about GOP presidential
nominee Bob Dole's comments that nicotine is not addictive,
Kessler responded that it is "scientifically not credible to say
that nicotine is not an addictive substance." When asked if
smoking is a freedom-of-choice issue, Kessler said, "Maybe you
can argue that the first cigarette smoked by a child of 13 or 14
is an issue of free choice, but certainly once they're addicted,
it's freedom denied." Kessler added that tobacco regulation is
"a high priority."
TOP JOB: When asked what he would like to be remembered
for, Kessler said, "The agency's reputation had been driven so
far down in a hole by the end of the '80s that anyone who came in
here as commissioner would have had to do something about public
confidence and public health. We've changed the label on
virtually every product in the supermarket. I mean, it's
readable; it's understandable" (Sexton/Biddle, 8/18).
REFORM SUPPORT: According to the Pharmaceutical Research
and Manufacturers of America (PhRMA), "12 governors and 20 state
legislatures representing 26 states have officially asked"
President Clinton and Congress to reform the FDA since the
beginning of the year. Among the states that PhRMA says support
FDA reforms are: California, Illinois, Massachusetts, Michigan,
Minnesota, New York, Pennsylvania and Virginia (PhRMA release,
DRUG PROMOTION: The American Pharmaceutical Association
(APhA) announced last week that it "supports the dissemination of
information related to specific conditions by pharmaceutical
manufacturers as one component of patient education." However,
since "confusion may arise from specific prescription product
promotion, as APhA does not support consumer-directed advertising
of specific prescription drug products." The APhA said that the
FDA's "consideration of modifications to the direct-to-consumer
promotion of prescription drugs ... must meet the FDA objective
of providing general, accurate information about the disease
state or condition affected, or the drug product."
SO FAR SO GOOD: The APhA said that it supports the current
brief summary requirements used by the FDA for prescription drug
advertising, but added that it must be used in conjunction with
"prescriber and pharmacist intervention." In addition, the APhA
said that it "reaffirms the validity of appropriate general
disclosure statements within direct-to-consumer promotions."
However, "a consistent message" must be present in order to
"remind patients that all drugs have side effects and potential
risks, and must be used with the guidance of health care
providers." According to the APhA, "the primary goal of
consumer-directed promotion ... should be to encourage consumers
to seek help for symptoms by contacting a health care
professional who will determine the appropriate therapy."
Direct-to-consumer advertisements "should provide awareness of a
treatable condition, not product claim information that could be
potentially misleading" (APhA release, 8/12).