Obama expected to bolster FDA oversight of imports
Source of Article: http://ap.google.com/article/ALeqM5h7JZh_mGMwGKL_zcf30rkmig7GBwD949LLS00 WASHINGTON (AP) — The Food and Drug Administration, bedeviled by a
salmonella outbreak and tainted medicine from China, is likely to monitor
imports and fresh produce more closely under an Obama administration. With President Bush no longer a roadblock, health officials also can
expect new powers to control tobacco, from cigarettes to the recently
introduced smokeless products called snus. President-elect Obama, a former smoker struggling to avoid relapse, is a
sponsor of legislation giving the FDA authority to control, but not ban,
tobacco and nicotine. Long seen as the government's premier consumer protection agency, the FDA
stumbled under Bush. Recurring drug and food safety lapses came against a
backdrop of shrinking budgets and long periods without a permanent leader. In
Congress, a senior Republican complained the FDA had gotten too cozy with
industry. Obama is being urged to move quickly to appoint an FDA commissioner.
Already more than a half-dozen names are in circulation: outside critics such
as Cleveland Clinic cardiologist Dr. Steven Nissen;
insiders such as Susan Wood, a former director of the FDA's women's health
office; and public health advocates such as Dr. Joshua Sharfstein,
Food safety will be a priority for Obama's FDA. "He thinks this is a
fundamental role of government to ensure that people's food is safe and he
has been concerned that we are not in a position to ensure that," said Neera Tanden, a senior campaign
adviser. Obama will be working with a Democratic-led Congress, including lawmakers
who have written legislation to bolster import inspections. Only a fraction of imported food is inspected now. Foreign drug
manufacturing plants can go years without an FDA visit. Democrats had
considered fees on industry to pay for more FDA inspectors, but could not
persuade the Bush administration to go along. They expect Obama to be
receptive. Tanden said Obama is open to the idea of
requiring a tracing system for fresh produce. That became an issue during
this summer's salmonella outbreak, after the FDA spent weeks hunting for
tainted tomatoes only to find the culprit might have been hot peppers. "An Obama administration would swing the pendulum back more to
protection of public health," said William Hubbard, a retired FDA
official who held top posts. "This bodes well for greater regulation in
the food safety area, on imports, and on drug safety." Under the tobacco proposal, the agency would be able to order changes in
tobacco products to make them less toxic and addictive, but could not ban
tobacco or nicotine. The bill passed the House and Senate with bipartisan
support, but a veto threat from Bush kept it from getting out of Congress. Aides to Sen. Edward M. Kennedy, D-Mass., co-author of the tobacco bill,
say there is strong interest in getting the legislation passed soon after the
new Congress convenes in January. Obama is a co-sponsor. The FDA could receive new powers from an Obama administration in the field
of biologic drugs. These medications are not made from chemicals but from
living cells, and represent the cutting edge of medical treatment for many
intractable diseases. Industry officials expect the Obama administration to work with Congress
to create a legal framework for the FDA to review and approve generic
versions of biologic drugs. Brand name biologics are very expensive, easily
costing $1,000 a month or more. |
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