Healthy Skepticism Library item: 1079

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Publication type: news

Kaufman M.
FDA Says It Can Force Change in Drug Sales Status
Washington Post 2003 Apr 26

Full text:

The Food and Drug Administration has concluded that it can force drugmakers
to switch some of their prescription drugs to over-the-counter medications
as a way to make them cheaper and more easily available to consumers, senior
FDA officials said yesterday.
The prospect of forced switches is strongly opposed by drugmakers, who say
that the policy could result in the unsafe use of some drugs. But the
momentum toward requiring drug companies to make certain products available
over-the-counter appears to be growing, and two popular prescription allergy
medications — Allegra and Zyrtec — will likely be the test cases if the
FDA decides to go forward.
FDA Commissioner Mark B. McClellan confirmed that the issue of forced
switches is being “actively considered,” and that the agency has concluded
it has the legal and regulatory authority to require them.
“Our first mandate is to make sure that drugs on the market are safe and
effective,” he said in an interview yesterday. “But we also need to be
conscious of the fact that health care cost and accessibility are a primary
concern to Americans, and that actions to address those issues support our
health care mission.”
Over-the-counter drugs are usually much cheaper than prescription drugs. But
the initial benefits of moving drugs to over-the-counter status typically go
to employers and insurance companies rather than consumers, because
insurance usually covers only prescription drugs.
McClellan, who is both a doctor and an economist, has emphasized the need to
hold down drug costs in a manner unusual for an FDA commissioner, and he has
looked to the over-the-counter market as one way to make medications
cheaper. The FDA’s proposed budget for 2004 includes a request for the first
increase in funding for its over-the-counter activities in almost 30 years,
and language that asserts that more drugs that require a prescription can be
sold safely on drugstore shelves.
The issue of switching drugs to over-the-counter status came up dramatically
last year with the allergy drug Claritin, one of the most widely prescribed
medications on the market and a very costly one for health insurers.
Responding to a citizen’s petition from a California health insurer to make
the drug available without prescriptions, the FDA encouraged the drug’s
manufacturer, Schering-Plough, to make the switch. The company initially
resisted, but later agreed to the change and so did not force the legal
issue of whether the FDA has the authority to require a switch.
The manufacturers of the two drugs under FDA consideration for forced
switches — Pfizer Corp.‘s Zyrtec and Aventis’s Allegra — say they oppose
the FDA efforts, as does the organization that represents the makers of
over-the-counter drugs. They also question whether the FDA has the legal
authority it claims — and the issue may be litigated if McClellan goes
ahead with efforts to force over-the-counter sales.
The makers of Allegra and Zyrtec are less likely to follow the example of
Schering-Plough and Claritin because their products still have many years of
lucrative protection against generic copies through their patents. Most of
the drugs that are sold directly to consumers over-the-counter are former
prescription medications for which the patents expired, and the makers of
Claritin agreed to sell over-the-counter only because the patent was set to
expire last year.
FDA officials said they have studied the issue of forcing companies to give
drugs over-the-counter status since the citizen’s petition in 1998, and
concluded recently that the agency has the legal right to do so. They rested
their conclusion, in part, on the FDA’s legal authority to regulate the
safety of all drugs, including whether or not they require a doctor’s
prescription to ensure the protection of patients.
“We believe we have the authority to determine whether or not a product is
Rx or OTC,” said John K. Jenkins, director for new drugs at the FDA’s Center
for Drugs and Evaluation. “The agency is being very careful to consider the
policy implications. This is setting agency policy.”
Drug company representatives said they are closely following the FDA’s
claims but did not indicate whether they would pursue legal action.
As part of its look at policy implications, an FDA official said the agency
is putting together possible “guidance” for the drug industry to follow
regarding over-the-counter switches in case it decides to go that direction.
Claritin, Allegra and Zyrtec are sold without a doctor’s prescription in
many other countries, and in some cases have been sold that way for many
years. An FDA advisory panel of specialists concluded in 2001 that the class
of drugs could be safely sold directly to consumers here and recommended
that the FDA work toward that end.
The FDA had one prior experience with a forced switch to over-the-counter
sales, and it was quickly rescinded. The makers of the antihistamine
metaproterenol, or Alupen, were tentatively required to sell their drug
without a prescription in 1982. But after opposition from doctors and some
negative reactions from patients, the company pulled the drug from the
shelves and the FDA rescinded its order.
The Consumer Healthcare Products Association (CHPA), which represents the
makers of over-the-counter drugs, referred to that experience in a letter
last month to the FDA and Health and Human Services Secretary Tommy G.
Thompson that opposed forced switches. “We understand that the FDA is
considering a switch of a second generation antihistamine, from prescriptionto OTC status, over the objections of the company,” wrote CHPA President
Linda A. Suydam.
“Attempting to force a switch would be a misallocation of FDA’s very limited
and finite resources available for OTC activities,” she wrote. “By diverting
OTC resources to try to force a switch where the sponsor is opposed, FDA
loses the opportunity to make important gains in OTC” regulation. She also
wrote that the FDA has a “significant backlog of switch applications” from
sponsors who want to move their products to over-the-counter status.
According to McClellan, the price of Claritin has dropped from $3 a pill as
a prescription drug to less than $1 a pill since going over-the-counter
early this year.
The chief beneficiaries so far have been insurance and drug benefit
companies, which no longer have to cover Claritin costs and often have
dropped Allegra and Zyrtec coverage as well. A monthly supply of
over-the-counter Claritin now costs more than the co-pay that many insured
patients were charged when it was a prescription drug. But McClellan said
the elderly and some uninsured are already paying less for Claritin and
everyone will in time as more generic versions of the drug come on the
market.
The FDA’s action is something of a response to the steep decline in the
number of drugs switching to over-the-counter status in recent years.
According to the newsletter Switch, compiled by the over-the-counter
consulting firm Francesco International, there were 21 significant and
advertisable drugs switchd to over-the-counter status in the major
drug-manufacturing nations in 1995, but only three in 2002.