Bayer - FDA issue

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UPDATE 3-US warns Bayer over aspirins containing supplements

Tue Oct 28, 2008 2:42pm EDT

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(Recasts, adds company and congressional comment, updates shares to

close)

By Heavey

WASHINGTON, Oct 28 (Reuters) - Two over-the-counter Bayer AG (BAYG.DE:

Quote <http://www.reuters.com/stocks/quote?symbol=BAYG.DE> , Profile

<http://www.reuters.com/stocks/companyProfile?symbol=BAYG.DE> , Research

<http://www.reuters.com/stocks/researchReports?symbol=BAYG.DE> , Stock

Buzz <http://reuters.socialpicks.com/stock/r/BAYG> ) aspirin products

that contain dietary supplements have not been proven to work and are

being sold illegally, U.S. health regulators warned on Tuesday.

Claims made about the products, Bayer Aspirin with Heart Advantage and

Bayer Women's Low Dose Aspirin + Calcium, also mislead consumers, the

U.S. Food and Drug Administration said.

" These are not FDA-approved products, " agency spokeswoman Rita Chappelle

said. " They are selling products that are illegal. "

The FDA stopped short of calling for the pain relievers to be removed

from store shelves but urged the company to take " prompt action " or else

face legal action.

But Bayer defended the medications and its right to market them.

" We stand behind both products and all marketing claims made in their

support, " the German drugmaker said in a statement.

The company added that its advertisements tell buyers to check with

their doctors before taking the combination aspirins. Bayer Aspirin with

Heart Advantage also tells consumers the drug does not replace

cholesterol-lowering medication.

Bayer Aspirin with Heart Advantage contains plant sterols and claims on

its packaging to help control cholesterol, while Bayer Women's Low Dose

Aspirin + Calcium claims to help strengthen bones and prevent

osteoporosis.

" These statements on the labeling send consumers a mixed message about

the purpose of the product and the duration for which it can be safely

used, " the FDA wrote in an Oct. 27 warning letter to the company

released on Tuesday.

FDA officials gave Bayer 15 days to respond to the warning. To comply,

the drugmaker could stop selling the products or conduct clinical trials

and seek FDA approval.

If the company does not take proper action, the FDA could seize the

product, seek an injunction or take other legal steps. Bayer said it was

reviewing the agency's letter.

The drugmaker's marketing of its Heart Advantage aspirin is also the

subject of a congressional investigation.

Earlier this month, the U.S. House of Representatives Energy and

Commerce Committee began probing whether Bayer misled the public by

marketing the combination product directly to consumers.

" Our investigation will continue, " committee Chairman Dingell, a

Michigan Democrat, said.

In its letter, the FDA confirmed Bayer's actions violated the agency's

policies.

Unlike drugs, supplements such as vitamins and herbs do not have to be

proven safe and effective before they can be sold in the United States.

But adding them to already-approved drugs makes them entirely new

products that must be subject to FDA review before being sold, the

agency said.

At the same time, the FDA has approved a variety of health claims for

certain foods and supplements that manufacturers can include on their

product packaging, such as the impact of plant sterols in reducing heart

disease.

Bayer earlier told the agency it was within its rights to market its

Bayer Heart Advantage, the FDA said citing a separate Aug. 18 letter

from the company.

In it, the drugmaker said the FDA and the U.S. Federal Trade Commission

support public education about aspirin's heart benefits, " and that a ban

on cardiovascular claims in consumer labeling for Bayer Heart Advantage

would violate Bayer's rights under the First Amendment, " according to

the FDA.

But the agency rebuked that argument, saying the U.S. Constitution does

not protect speech that is false, misleading or concerns illegal

activity.

It is the agency's duty to scrutinize new products because otherwise

consumers could waste money and " more importantly, rely to their

detriment on a drug product which did not go through the requisite

regulatory review, and could prove harmful, " it said.

The American Herbal Products Association, which represents supplement

manufacturers, has been seeking FDA guidance on the marketing of

combination drug-supplement products, but criticized the agency's

action.

" FDA could have developed a streamlined science-based policy to control

the introduction of health promoting products, rather than forbid all

combination products, " the group's president, McGuffin, said.

After the FDA warning, Bayer shares trimmed gains to close up about 1

percent on the German exchange. (Editing by Dave Zimmerman and Andre

Grenon)

S. Kalman PhD, RD, CCRC, FACN

Miami Research Associates

Director, Nutrition & Applied Clinical Research

6141 Sunset Drive #301

Miami, FL. 33143

(fax)

www.miamiresearch.com <http://www.miamiresearch.com>