[e-drug] USA proposes rapid review of FDCs and coblistered ARVs

[e-drug@healthnet.org]

E-DRUG: USA proposes rapid review of FDCs and coblistered ARVs
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[Details of a new USA plan to compete with the existing UN
pre-qualification project; WB]

http://releases.usnewswire.com/GetRelease.asp?id=102-05162004

HHS Proposes Rapid Process for Review of Fixed Dose Combination and
Co-Packaged Products

To: National Desk

Contact: HHS Press Office, 202-690-6343

WASHINGTON, May 16 /U.S. Newswire/ -- HHS Secretary Tommy G. Thompson
today announced an expedited review process to ensure that the United
States is providing safe, effective drugs to developing countries under
the President's $15 billion Emergency Plan for AIDS Relief.

U.S. Global AIDS Coordinator Randal L. Tobias said the new process will
enable his office to ensure the quality of drugs purchased by the United
States for developing countries under the President's Emergency Plan for
AIDS relief. Under the new guidance to be proposed next week by HHS'
Food and Drug Administration (FDA), the United States will be able to
provide life-saving drugs at lower prices to millions of people in
Africa and the Caribbean.

Secretary Thompson and Ambassador Tobias said drug patent issues that
apply in developed nations should not impede purchase of these drugs for
developing countries. The FDA guidance will apply to new products that
combine already-approved individual HIV/AIDS therapies into a single
dosage, known as fixed dose combinations (FDC), as well as to new
co-packaging of existing therapies. Drugs that are approved by FDA under
the process described in the guidance will meet all FDA standards for
drug safety, efficacy, and quality, said Acting FDA Commissioner Lester
M. Crawford.

The expedited review process, combined with the work of local drug
regulatory authorities in the affected countries, will provide a
mechanism to ensure that safety, efficacy and quality standards are met
and maintained by companies providing drugs for the President's
Emergency Plan for AIDS Relief. President Bush has pledged $15 billion
for this initiative to address the global HIV/AIDS pandemic in
developing nations, through prevention, care and treatment programs that
include the purchase of HIV/AIDS drugs.

"We are clearing the way to quickly deliver quality, life- saving
HIV/AIDS drugs to people who desperately need them in developing
countries," Secretary Thompson said. "We are committed to ensuring that
President Bush's Emergency Plan for AIDS Relief is providing medical
care as effectively and efficiently as possible. Fixed dose combination
products and co-packaged products are an important tool in improving the
quality of health care in developing nations."

"The President has made clear that his goal is to put effective
treatment into the hands of those who need it in the hardest-hit
developing nations, and to provide these life-saving services as widely
as possible," said Ambassador Tobias. "At the same time, we must apply
real discipline to ensure that the products we provide in poor nations
are safe and effective. The new expedited process provides us with a
solid foundation for purchasing drugs that work. With FDA review, we
will have a gold-standard assurance that a combination product will be
safe and effective."

The guidance will outline four scenarios for review of different FDC and
co-packaged products. Some of the scenarios could permit approval in as
little as two to six weeks after submission of a high quality
application. For companies making products where another firm owns the
U.S. patent rights, FDA could issue a tentative approval when it finds
the product meets the agency's normal safety and efficacy standards.

Ambassador Tobias commended Secretary Thompson for developing the new
guidance. "The Office of the U.S. Global AIDS Coordinator would
recognize this 'tentative approval' by FDA as evidence of the safety and
efficacy of AIDS drugs to be purchased under the President's Emergency
Plan for AIDS Relief. We can then use these drugs in developing
countries, where international patent agreements permit them to be
purchased," he said. "What is most important is that we must only
purchase products that have undergone scientifically rigorous safety and
efficacy review. This initiative on the part of FDA will enable just that."

Control of HIV/AIDS generally requires use of several different drugs
simultaneously. Combination products would bring together different
HIV/AIDS drugs in a single medication or co- package, thereby
facilitating patients' compliance with often complicated drug regimens.

To obtain approval of new products, manufacturers could cite existing
clinical data to demonstrate the safety and effectiveness of the
individual drugs in the new combined product -- and new data to show
effectiveness of the new combination could be developed quickly. FDA
pledged to work with companies in assuring that necessary data are
developed rapidly if the companies do not already have access to such data.

Secretary Thompson urged manufacturers of brand-name and generic drugs
alike to work with FDA and submit applications. "HHS has opened the door
to rapid review of new combination products," he said. "This means
companies will have new incentives to develop easy-to-use products at
lower prices. It also means we will provide a sound scientific basis to
Ambassador Tobias for the very substantial purchases that the
President's Emergency Plan will be making on behalf of millions of
people in the hardest hit nations. This is essential - to skirt the
safety and efficacy issues would be wrong and dangerous."

Acting FDA Commissioner Crawford also announced that FDA is evaluating
whether the agency can waive or reduce user fees, normally charged to
companies making new drug applications, for products reviewed under this
rapid review process.

"FDA recognizes the public health importance of these products and is
evaluating the circumstances under which it may grant user fee waivers
for sponsors developing products under this guidance. FDA intends to
expedite the development process for these products as much as is
practicable. FDA intends to maximize the many benefits, including the
potential to limit the development of drug resistance, while preventing
serious risks such as overlapping toxicities and the potential for
inappropriate combinations to increase the amount of virus in the body,"
Dr. Crawford said.

The guidance will include a list of currently approved drugs for which
FDA believes there exist clinical safety and efficacy data supporting
combination use. There are more than 20 unique anti-HIV medications
approved in the United States.

The draft guidance will be open for a 60-day comment, but it is
effective and active immediately.

---

http://releases.usnewswire.com/GetRelease.asp?id=103-05162004

Fact Sheet: HHS Proposes Rapid Process for Review of Fixed Dose
Combination and Co-Packaged Products

To: National Desk

Contact: HHS Press Office, 202-690-6343

WASHINGTON, May 16 /U.S. Newswire/ -- Secretary of Health and Human
Services Tommy G. Thompson, Global AIDS Coordinator Randall Tobias, and
Acting Food and Drug Administration (FDA) Commissioner Lester Crawford,
announced an expedited pathway for FDA to review low-cost, safe and
effective fixed dose combination (FDC-creating one pill out of two or
three individual drugs), co- packaged (putting two or more pills into
single packaging for distribution) and single ingredient HIV therapies
for use under the President's Emergency Plan for AIDS Relief.

HHS FACT SHEET

What drugs can be reviewed through this pathway?

-- Brand-Name Fixed-Dose Combination and Co-Packaged HIV Therapy Drugs.
Today's action encourages the development and provides expedited review
for applications from brand-name companies (research and development
based companies that hold the original patent for the individual drugs
used to make up the FDC) for FDC and co-packaged HIV therapy drugs
composed of drugs previously approved by FDA.

-- Non-Brand-Name Fixed-Dose Combination and Co-Packaged HIV Therapy
Drugs. FDA will also provide expedited review for applications from non
brand-name companies for FDC and co- packaged HIV therapy drugs composed
of drugs previously approved by FDA. Non-brand-name companies can submit
applications on their own or develop partnerships with brand-name companies.

-- Non-Brand-Name Single Ingredient Drugs. Today's action also provides
expedited review from non-brand-name companies for generic forms of
already approved single-ingredient HIV therapy drugs.

What scientific information is required from Applicants?

-- Existing Clinical Data. FDA's expedited review process for FDCs or
co-packaged drugs encourages companies to rely on existing data,
including published literature, to support labeling for the combined use
of already approved drugs rather than developing new clinical data.
Normally, it takes a company 3-4 years to develop this information.
FDA's guidance provides a list of currently approved drugs for which the
agency believes there are sufficient clinical data. In addition FDA will
consider the following types of information in lieu of new clinical data:

o Peer-reviewed scientific literature reports of clinical studies. FDA's
guidance provides a list of drugs currently approved by FDA for which
there are sufficient clinical data.

o Reference to a company's own relevant data including data already
submitted to FDA.

o Cross-reference to another company's data (for which the applicant has
obtained the reference rights).

o Reliance on FDA's findings of safety and effectiveness for an approved
drug product.

-- Chemistry. For co-packaged brand-name products, only data showing
that the drugs are stable in the new package will be needed. For new
FDCs information showing that the combined drugs do not react with one
another will be necessary. If a manufacturer has never submitted a
description of the manufacturing process to FDA, additional information
would be needed.

-- Bioavailability Study. A bioavailability study is needed to show that
the blood levels of the products when used in combination are at levels
comparable to that achieved by the drugs used alone.

-- Manufacturing Inspection. Plants manufacturing these products will
have to pass an FDA quality inspection.

What are the time frames for review?

-- Once FDA receives a completed application, it anticipates completing
review of FDCs within 6 weeks. Review of applications for co-packaged
products consisting of individually approved components with new
combination labeling could be completed more quickly. FDA will provide
technical assistance to those not familiar with the FDA process. FDA
will also provide basic technical assistance to manufacturers who do not
currently market a product, but wish to develop a product.

What will FDA review cost companies submitting applications?

-- For new drugs, FDA typically charges a user fee of over $500,000.
Congress has provided the Agency with authority to grant waivers of
these fees when appropriate. To minimize the cost of submitting an
application for review, FDA anticipates waiving fees for products
proposed for use under the President's Emergency Plan for AIDS Relief.

How much will the drugs cost?

-- The process announced today does not directly relate to price. The
Global AIDS Coordinator will create a competitive process to procure the
lowest price in the future. Nonetheless, this pathway should
significantly increase the number of companies and products that will
compete for the Coordinator's procurement. It has been claimed that some
HIV/AIDS therapies may cost as low as $140 per year. All companies with
products are encouraged to participate in this process and compete in
the procurement.

Note: All HHS press releases, fact sheets and other press materials are
available at http://www.hhs.gov/news
<http://releases.usnewswire.com/redir.asp?ReleaseID=30521&Link=http://www.hh
s.gov/news>.

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