Healthy Skepticism Library item: 1037

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Publication type: news

White V.
Lawmakers Accuse FDA of Siding with Industry on Reimportation From Canada
2003 Apr 4

Full text:

In the controversy over reimporting prescription drugs from Canada, the
Food and Drug Administration seems to be siding with drug manufacturers to
guarantee the continuity of their substantial profits, rather than helping
the American public to get affordable drugs, members of a House
subcommittee said April 3.
At a hearing of the House Government Reform Subcommittee on Human Rights
and Wellness, several member maintained that, if FDA officials wanted to
ensure that drugs ordered from Canadian pharmacies were safe and
well-regulated, they could address that issue directly.
Reimportation of drugs from Canada has been going on for about 16 years,
according to Rep. Dan Burton (R-Ind.), chairman of the subcommittee. The
fact that FDA did not try to stop it until GlaxoSmithKline had a problem
seems a “very strange coincidence,” he said.
In January, GlaxoSmithKline (GSK) cut off supplies to Canadian wholesalers
and distributors who participated in the sale of prescription drug to
American consumers. Soon after, FDA announced it would be taking
enforcement actions against similar companies.

‘Strange Coincidence.’
Burton said he was sure GSK was fighting this issue because of the
potential loss of millions of dollars in profits if Americans continued to
buy a large volume of prescription drugs from Canadian pharmacies.
“FDA is influenced by the pharmaceutical industry, and anyone who doesn’t
see that has their eyes closed,” Burton said. “I think it is a strange
coincidence that, as soon as GSK puts pressure on these companies to stop
selling to Americans, the FDA begins focusing on a non-problem.”
On March 21, FDA joined the Arkansas State Board of Pharmacy in issuing a
warning letter to Lowell, Ark.-based Rx Depot, accusing the company of
running a “storefront operation” that resulted in the reimportation and
distribution of drugs from Canada. The letter instructed the firm to cease
violating state law immediately.
Burton said that, instead of threatening the American public by telling
them that buying drugs from Canada is against federal law, the agency
should do a study on how many people had been affected by the high costs of
drugs in this country.
Rep. Bernie Sanders (I-Vt.) said he did not think FDA’s recent change of
heart on this topic was a coincidence. He said he believes FDA feels
compelled to work with the drug manufacturers because of the industry’s
millions of dollars in political contributions. “I think they are [working
with them] because the drug companies are now asking for payback…. They
have spent millions of dollars in political process, and now they are
calling in those chips.”

Public Safety
William Hubbard, FDA’s associate commissioner for policy, planning and
legislation, disagreed with committee members’ accusations, and said that
recent enforcement efforts were motivated by nothing more than concern for
public safety. Just because a Web site claims to be in Canada, does not
necessarily mean that is where it is, he said. “And if we don’t know where
they are, we don’t know where there drugs are coming from.”
Hubbard admitted that he could not say that the Canadian regulatory system
was any less stringent than that of the United States. He also said that,
to date, there have been no cases of American citizens being harmed from
drugs imported from Canada but said once you allow “that door to open,
nefarious characters will get in.”
He said the agency fears that allowing Americans to buy from these Web
sites and storefront intermediaries will result in someone being harmed by
a counterfeit or contaminated drug.
However, Burton pointed out that former FDA Commissioner David Kessler said
that he believed the reimportation of drug products was possible without
jeopardizing American consumers. Hubbard said he disagreed with that
statement.
“You’re sitting there in your ivory tower saying you don’t know about
Canada’s regulatory system, and yet you’re making these decisions and
telling American seniors that ‘if you’re buying drugs from Canada, you
might be breaking the law,’ “ Burton said. “The seniors that are doing this
may not be as sophisticated as you or I, and they may know that you’re not
really going to prosecute them, but you’re scaring the hell out of them.”

Do Something About It
Burton told Hubbard he did not understand how FDA could maintain that
anyone was violating the law, when in 2000 the Clinton administration
signed into law a bill that would have permitted drug reimportation from a
number of countries, including Canada.
Neither the Clinton administration nor the Bush administration actually
implemented that law, however, citing concerns about safety and cost
savings.
Burton said it is not FDA’s job to make laws; it is their job to enforce
them and, he added, the agency needs to do some “out of the pill box”
thinking to implement that three-year-old piece of legislation.
Rep. John Tierney (D-Mass.), who is a member of the full committee but not
the subcommittee, said, “This committee would be derelict in its duty if we
do not ensure that the American public gets a fair and reasonable price for
what they have given to drug companies.”
Rep. Gil Gutknecht (R-Minn.), who requested the hearing, noted that the
antibiotic Augmentin is sold for $55.50 for a one month supply in the
United States, whereas in Canada it costs $12.00. He said “There is
something wrong with a system that allows these huge disparities.”
Gutknecht also pointed out that 2 percent of the food imported from other
countries is contaminated with viruses, including salmonella, but FDA,
which also regulates that industry, has taken no stand against that. Burton
added that Americans are much more likely to get sick from a strawberry
than from these reimported drugs.
Sanders asked, “How can the federal government say it’s okay for us to
consume fruits and vegetables from God knows where, but then say it can’t
find a way to regulate these few Web sites with a country as advanced as
Canada that has a regulatory system as good as ours?” Answering his own
question, he said, “You could do it you wanted to do it.”

Working With Canada Suggested
“Why don’t you require that Canada use counterfeit-proof blister packs for
these reimported drugs from Canada, to ensure drugs can be purchased at a
lower price with limited risk,” Burton asked.
He also wanted to know why FDA cannot work with the Canadian government to
ensure these sites are valid or require safety seals on the products to
know the product has not been tampered with. “The only reason I can think
of is money.”
“To say that you can’t do it really bothers all of us,” Burton said. “We
passed NAFTA [North American Free Trade Agreement] so we could trade with
Canada and Mexico. So how can you say you can’t go over there to figure out
a way to accredit these sites?”
Hubbard maintained that his agency does not have the authority to assess
the regulatory systems of other countries, certify their Web sites, or
place packaging requirements on them. He said FDA has looked at a number of
ways to allow the reimportation of prescription drugs from Canada, but
cannot eliminate the risk.
“This isn’t going away,” Burton said. “I’m going to be the chairman of this
committee hopefully for the next six years and Mr. Gutknecht is going to
get all the hearings he wants until something is done about it.”
Copyright © 2003 by The Bureau of National Affairs, Inc., Washington D.C.