UPDATE 1-Critics cite Avandia in pushing FDA safety reforms

* Renewed calls for stronger post-approval safety office

* Cardiologist says companies should release more data

(Adds comment from drug industry group)

By Lisa Richwine

WASHINGTON, April 28 (BestGrowthStock) – The controversy
surrounding a GlaxoSmithKline Plc (GSK.L: ) diabetes drug points
to a need for changes in the way the U.S. Food and Drug
Administration handles safety issues, agency critics told
lawmakers on Wednesday.

The FDA is taking a new look at the safety of Glaxo’s
Avandia pill, which carries a warning about heart risks. The
manufacturer says the drug is safe and effective, and the FDA
is advising patients to keep taking the drug as directed.

Two drug safety reviewers have recommended that the drug
come off the market after concluding it was more dangerous to the
heart than rival drug Actos by Takeda Pharmaceutical Co Ltd
(4502.T: ).

That has prompted new calls for more independence and power
for the reviewers who analyze a drug’s risks after it reaches
the market, an idea circulating for years. Critics say more
authority lies with the staff who approve drugs and are
therefore reluctant to withdraw a medicine they supported.

“Individuals in the office responsible for post-market
surveillance should be allowed to provide an independent
opinion based on the best available evidence,” Republican
Senator Charles Grassley told a House of Representatives
Appropriations subcommittee.

The FDA has said it is undertaking an internal review of
drug safety decision-making in addition to bringing Avandia to
an advisory panel of outside experts in July. “This review will
make recommendations regarding the agency’s approach to safety
issues including Avandia,” FDA spokeswoman Karen Riley said on

A panel that met in 2007 heard from a safety reviewer who
felt the drug should no longer be sold. That panel voted 22-1
that Avandia was safe enough to stay on the market.

Representative Rosa DeLauro, the subcommittee’s chairwoman,
said the “evidence suggests that we should look into
strengthening either the independence or the powers of the
FDA’s drug safety office so that its recommendations no longer
go unheeded.”

DeLauro said she wanted to provide input to the FDA ahead
of the July advisory panel meeting. She also said she might
pursue FDA safety reforms when her panel is setting funding
levels for the agency.

“We would like to address some of these issues,” she said.

Another witness at Wednesday’s hearing, Dr. Harlan
Krumholz, said drugmakers should disclose more clinical trial
data so independent researchers can evaluate it.

Companies must release summaries of study results but
should also provide raw data with more details, Krumholz said.

“I still don’t think we know the full story (on Avandia).
We have not seen the raw data,” said Krumholz, a Yale
University cardiologist.

Drugmakers said in a statement the FDA already looks at the
raw data. “An independent analysis of the raw scientific data
already occurs” as part of the FDA review process, said David
Wheadon, a senior vice president at the Pharmaceutical Research
and Manufacturers of America.

The FDA scientists are “best equipped” to evaluate the drug
benefits and safety and often turn to outside experts on
advisory panels for input, Wheadon said.

On Avandia, the FDA decided in 2007 Avandia should carry a
warning, saying a review of 42 studies associated the drug with
an increased risk of a heart attack or chest pain compared with
a placebo. But it said overall data were “inconclusive.”

Avandia returned to the spotlight in February after
Grassley and Senate Finance Committee Chairman Max Baucus
released internal FDA documents and a report that criticized
the handling of the drug by Glaxo and the FDA.

Sales of Avandia topped $3 billion in 2006 but fell to $1.2
billion in 2009.

In a statement, Glaxo said it “stands behind the safety and
efficacy of Avandia when used appropriately” and that “the
totality of new and existing data” on the drug’s safety would
be presented at the July panel meeting.

The company also has said it has been open about providing
information on the drug to the FDA.

DeLauro said she did not invite the FDA or Glaxo to the
hearing because they are preparing to address Avandia at the
July panel meeting.

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(Reporting by Lisa Richwine; Editing by Steve Orlofsky)

UPDATE 1-Critics cite Avandia in pushing FDA safety reforms