E-DRUG: USA proposes rapid review of FDCs and coblistered ARVs (2)
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[more data from FDA and 2 press reviews of the new USA FDC policy; WB]
The draft guidance from FDA and the federal registry notice are now
available on the Internet:
http://www.fda.gov/oc/initiatives/hiv/default.htm
Asia Russell
asia@CritPath.Org
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[From New York Times; copied as fair use; WB]
http://www.nytimes.com/2004/05/17/health/17AIDS.html
U.S. Speeding Up Approval Steps for AIDS Drugs
By LAWRENCE K. ALTMAN
New York Times
May 17, 2004
WASHINGTON, May 16 � The Bush administration announced a significant
shift in its AIDS policy on Sunday, expediting the approval process for
generic and combination antiretroviral drugs so they can be purchased at
lower prices and provided more efficiently and safely to millions of
infected people in Africa and the Caribbean.
The expedited process is also designed to encourage manufacturers to
create a single pill, consisting of two or three licensed antiretroviral
drugs. The combination of these drugs in single, easy-to-dispense
packages could help eliminate the confusing jumble of dosages that can
hamper compliance with AIDS treatment, especially among the poor and
illiterate.
The quicker process is intended to encourage manufacturers to produce
the fixed-dose combinations to ease delivery of drugs in remote areas in
severely affected countries and to make their use safer.
At the same time, the Food and Drug Administration will more rapidly
review applications from foreign manufacturers to sell as generics in
developing countries antiretroviral drugs patented in the United States.
Such approved generic drugs will be eligible for purchase under the Bush
administration's $15 billion AIDS relief program, largely for countries
in Africa and the Caribbean.
Approval for some combinations and generics could take as little as two
to six weeks, said Tommy G. Thompson, the secretary of health and human
services. Such approvals usually take six months, he said.
Mr. Thompson announced the policy change at a news conference in Geneva,
where delegates from the World Health Organization were gathering for
the group's annual meeting, which begins Monday.
The Bush administration had been expected to be the target of heavy
criticism at the weeklong meeting for its previous reluctance to approve
inexpensive combinations of patented antiretroviral AIDS drugs. In the
past, the United States insisted on more stringent criteria than the
World Health Organization had already required for inexpensive generic
copies of these drugs and for approving fixed-dose combinations of them.
Advocacy groups for AIDS patients had accused the Bush administration of
bowing to pressure from the American pharmaceutical industry by delaying
approval of less costly generic copies to promote the sales of the more
expensive, patented original drugs. The policy change announced Sunday
could blunt much of that criticism.
At the news conference, Mr. Thompson declined to estimate how long it
would take for antiretroviral drugs to reach the people who need them
once they had been approved.
It was unclear what specifically had contributed to the administration's
change of policy, although the American pharmaceutical industry had
clearly been briefed about it in advance. Some big drug companies
quickly issued favorable responses.
International health officials also welcomed the announcement.
"It's a pretty radical change in U.S. policy, if applied," Dr. Peter
Piot, the director of the United Nations AIDS program, said Sunday in a
telephone interview from his office in Geneva.
"It will help AIDS treatment programs everywhere," Dr. Piot said.
Reducing the cost of antiretroviral drugs is only one step in stopping
the AIDS epidemic. Other major issues include: distributing the drugs to
areas that are accessible only on foot or by bicycle; the lack of
testing centers; rudimentary health care systems in much of the
developing world and inadequate medical staff.
From a public health perspective, Dr. Piot said, fixed-dose
combinations should increase the availability of antiretroviral drugs in
remote areas and be safer for patients. Taking one pill, or a small
number of pills should increase patient compliance and help prevent the
development of resistant strains of H.I.V., the virus that causes AIDS,
he said.
Dr. Piot said he expected the new plan to increase competition among
drug manufacturers by expanding the market for antiretroviral drugs.
"I'm very, very positive about it," he said.
The White House's global AIDS coordinator, Randal L. Tobias, said in
Geneva that he hoped that drug manufacturers would start applying for
approval under the new policy as soon as possible. Mr. Tobias is a
former chairman and chief executive of the American pharmaceutical
company,Eli Lilly.
A number of drug companies said they would work together to market a
fixed-dose combination.
Merck, Bristol-Myers Squibb and Gilead Sciences said in a joint
statement that they were in discussions to develop a one-pill
combination of three antiretroviral drugs and are considering packaging
certain products together.
The single pill would include two Gilead drugs � tenofovir disoproxil
fumarate, which the company sells under the brand name Viread, and
emtricitabine, which it sells under the brand name Emtriva � and a third
drug, efavirenz. Bristol-Myers Squibb markets efavirenz under the brand
name Sustiva in the United States, Canada and some European countries;
Merck sells efavirenz as Stocrin elsewhere.
In March, Gilead filed regulatory applications in the United States and
Europe for approval of a single tablet, fixed-dose combination of Viread
and Emtriva.
In a separate announcement, two other big pharmaceutical companies,
GlaxoSmithKline and Boehringer Ingelheim, said they had entered into
discussions to assess the development of packaging antiretroviral drugs
together for use in poor countries.
Companies must show that putting three medicines into one pill or
package does not make them unsafe or less effective, the government
said. Government officials said they would accept existing data from
drug companies to support approval of currently licensed antiretroviral
drugs instead of requiring data from new trials. Usually it takes three
to four years to develop such information, Mr. Thompson and Mr. Tobias said.
In a signal to manufacturers about the government's new plan, the Food
and Drug Administration said it would provide technical assistance to
foreign companies not familiar with the agency's regulatory process.
Mr. Thompson said foreign manufacturers of generic antiretroviral drugs
could receive approval for pills packaged together in two to six weeks
and for pills combining three medicines in four to eight weeks.
Lester M. Crawford, the acting commissioner of the F.D.A., said that the
agency was determining whether it could waive or reduce the $500,000 or
more in fees companies pay when applying for approval of new drugs.
Fiona Fleck contributed reporting from Geneva for this article.
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[From the Wall Street Journal; copied as fair use]
U.S. Says 3-in-1 AIDS Drugs For Poor Nations Need Review
By SARAH LUECK
Staff Reporter of THE WALL STREET JOURNAL
May 17, 2004; Page B2
WASHINGTON -- The Bush administration said 3-in-1 AIDS drugs must win Food
and Drug Administration approval before the U.S. buys them for developing
countries, prompting criticism from advocacy groups who called the process
an unnecessary barrier.
FDA officials said the process would be simple and speedy, perhaps taking
four to six weeks once an application is complete. They also said companies
in India already making the combination drugs would be eligible to win FDA
"tentative approval'' recognizing their safety and effectiveness, even
though they couldn't be sold here due to patent protections.
Further, the expedited process would increase the pressure on brand-name
drug makers to formulate their own combination treatments and cause them to
reduce their prices, officials said. And the FDA is instructing companies on
what they need to do to win approval for co-packaging three separate AIDS
drugs, a more likely near-term option.
"We will create a level playing field for all companies willing to submit
applications for review," said Health and Human Services Secretary Tommy
Thompson.
"We've been pressing to have an expedited system," said Mark Isaac, vice
president of the Elizabeth Glaser Pediatric AIDS Foundation, a recipient of
administration treatment funds.
Some AIDS advocacy groups said the combination drugs, already being used in
sub-Saharan Africa, shouldn't be required to clear any FDA hurdles. The
groups have pressed the administration to buy the cheaper Indian-made
treatments, which received "pre-approval" from the World Health
Organization.
Requiring the drugs to get FDA approval is "a dangerous precedent, in our
estimation," said Paul Zeitz, executive director of the Global AIDS
Alliance. "While this sounds like a fast-track, it's a delay."
William Haddad, speaking for Bombay-based Cipla, one of the Indian companies
that makes a combination AIDS drug, said the process is "unnecessary, it's
unwarranted, and we think it's a political act." He thinks the approval
process will take longer than a few weeks.
A U.S purchase of the Indian-made drugs would have been problematic for the
brand-name drug industry, which is fighting a domestic political battle
against allowing prescription drugs to be imported from other countries
where they are cheaper. U.S. endorsement of WHO "pre-approval" would have
lent credibility to a process that is encouraging the use of copies of
branded drugs.
Bush administration officials said they want to ensure safety and quality of
drugs bought for international use, not reacting to drug-industry pressure.
Bristol-Myers Squibb Co., Gilead Sciences Inc. and Merck & Co. Inc. said
that they are in discussions on the development of a combination drug that
would combine three separate AIDS drugs that they make. The companies said
they are working on co-packaging the drugs. One component can cause birth
defects, so it won't be suitable for pregnant women, unlike the Indian-made
combination drugs.
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