FDA: Another tainted drug crisis seems inevitable

heparin_facility_china.gi.top.jpgAs more drugs sold in the U.S. are manufactured overseas, FDA warns it can't guarantee their safety. By Parija Kavilanz, senior writer


NEW YORK (CNNMoney) -- A senior Food and Drug Administration regulator warned that another public health crisis may be inevitable because the agency can't guarantee the safety of many drugs and food products manufactured overseas.

"The safety of America's food and medical products is under serious challenge," John Taylor, FDA's acting principal deputy commissioner, said Monday.

He said the safety agency must reinvent itself to operate more effectively globally, or "another public health crisis like Heparin seems inevitable."

In 2008, contaminants in Heparin, a blood thinner being produced in China, led to more than 100 deaths in the United States.

The FDA is responsible for overseeing the safety and manufacturing quality of food, drugs, medical devices, vaccines, cosmetics and tobacco products.

Speaking at the Pew Health Group conference in Washington D.C., Taylor said the FDA can't keep up with how quickly manufacturing has shifted overseas.

Decades ago, Taylor said the agency had a better grip on ensuring the safety of those products because most of them were made in the United States.

But today, he said, the agency is crippled in its mission to protect the health of Americans since a lot of medicine sold in the U.S. is made abroad and outside of strict FDA oversight.

40% of drugs consumed in the United States are imported, while 80% of the ingredients used in U.S. drugs come from other countries.

And food imports have grown on average 10% each year for at least 7 years, he said.

"Today, there are more than 130,000 importers of record and more than 300 ports of entry in the United States," he said.

Taylor said the FDA's difficulty in monitoring imports is also leading to more counterfeit and adulterated products entering the U.S.

One recent high-profile incident was the contaminated Heparin from China that killed more than 140 people in the United States. Other incidents include toothpaste from China containing Diethylene Glycol -- used in antifreeze -- counterfeit Lipitor from Central America and counterfeit glucose monitor test strips.

The next few years, he said, are critical for the agency to transform itself to adapt to the global challenges.

Taylor provided a glimpse of what he called the FDA's "global strategy and action plan."

Among his key points: the FDA will partner with its foreign counterparts to create a global coalition of regulators; it will boost intelligence gathering and the agency will encourage consumers and the private sector to help in its efforts.

"Regulators cannot do it alone," said Taylor.  To top of page

Frontline troops push for solar energy
The U.S. Marines are testing renewable energy technologies like solar to reduce costs and casualties associated with fossil fuels. Play
25 Best Places to find rich singles
Looking for Mr. or Ms. Moneybags? Hunt down the perfect mate in these wealthy cities, which are brimming with unattached professionals. More
Fun festivals: Twins to mustard to pirates!
You'll see double in Twinsburg, Ohio, and Ketchup lovers should beware in Middleton, WI. Here's some of the best and strangest town festivals. Play
Index Last Change % Change
Dow 16,804.71 -238.19 -1.40%
Nasdaq 4,422.09 -71.31 -1.59%
S&P 500 1,946.16 -26.13 -1.32%
Treasuries 2.40 -0.10 -4.19%
Data as of 3:29am ET
Company Price Change % Change
Bank of America Corp... 16.82 -0.23 -1.35%
Ford Motor Co 14.59 -0.20 -1.35%
Facebook Inc 76.55 -2.49 -3.15%
Apple Inc 99.18 -1.57 -1.56%
Cisco Systems Inc 25.03 -0.14 -0.56%
Data as of Oct 1

Sections

In the last five years, pumpkin sales have risen 34% as people demand pumpkin in everything from beer to beef jerky. More

Facebook's chief product officer issued an apology to Sister Roma and the drag community on Wednesday for its flawed 'real name' policy. More

New York City launches a comprehensive site for all things related to its digital tech scene, Digital.NYC. More

For these seniors, the best retirement is not to retire. From a 102-year-old Wal-Mart worker to an activist park ranger, these workers have stayed on the job well into their golden years. More

Market indexes are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer Morningstar: © 2014 Morningstar, Inc. All Rights Reserved. Disclaimer The Dow Jones IndexesSM are proprietary to and distributed by Dow Jones & Company, Inc. and have been licensed for use. All content of the Dow Jones IndexesSM © 2014 is proprietary to Dow Jones & Company, Inc. Chicago Mercantile Association. The market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. FactSet Research Systems Inc. 2014. All rights reserved. Most stock quote data provided by BATS.