[Ip-health] News: PharmaTimes- Most Americans "don't believe Chinese, Indian-made drugs are safe"

Terri - Louise Beswick Terri at haiweb.org
Thu Aug 5 09:03:03 PDT 2010

Most Americans "don't believe Chinese, Indian-made drugs are safe"

05 August 2010


70% of Americans are "not confident" that prescription drugs made in
China are safe and free from contamination, and 54% have the same
reservations about medicines produced in India, according to a new


In contrast, only 4% of Americans lack confidence that drugs made in the
USA are safe and free from contamination, while for other
overseas-produced medicines, the percentages of US consumers who are
"not confident" are 9% for drugs made in Canada, 12% for Swiss-made
medicines and 16% for those produced in Ireland, according to the poll,
published this week by the Pew Prescription Project health policy think


It also finds that 76% of Americans aged 18-34 believe that prescription
drug contamination is "a serious problem," although the percentages
holding this view decline as people grow older, dropping to 63% of those
aged 65 and over.


Publication of the poll's findings coincided this week with the
introduction in Congress of Colorado Democrat Senator Michael Bennet's
Drug Safety and Accountability Act of 2010, which aims to give the Food
and Drug Administration (FDA) stronger powers to protect the US
pharmaceutical supply chain.


The Act would establish quality standards for the FDA, drug companies
and their contractors - which are increasingly based overseas. It would
also provide the agency with additional recall powers and other
enforcement options, and improve the federal government's tracking
systems of manufacturing sites.


"For too long, the FDA has lacked the proper authority to adequately
safeguard our drug supply," says Sen Bennet.


2009 saw a record 1,742 drug recalls in the USA - a 400% increase from
the prior year, and the vast majority were related to manufacturing
quality and testing, say the bill's supporters. Up to 80% of the active
ingredients in US drugs are now made overseas, many in countries where
regulatory oversight does not meet US standards, yet imported drugs
receive less than 5% of the FDA's resources, they add.


The proposed legislation would also provide new oversight of
over-the-counter (OTC) drugs. The FDA has traditionally focused
oversight on manufacturers of prescription drugs, but serious quality
issues have been identified at a number of OTC plants in recent years,
and the Act would prevent the FDA from relegating OTCs to a lower-risk
category for site inspection simply because of their status.


Sen Bennet's bill is supported by the Pew Prescription Project and a
number of other organisations including seniors advocacy group the AARP,
the American College of Physicians, Consumers Union, the Society of
Chemical Manufactures and Affiliates and consumer health group Community


Commenting on the poll's findings, spokesmen for Pew point out that, in
the wake of more than 100 US deaths associated with contaminated heparin
from China, Americans' trust in imported drugs has been badly shaken.
Following last year's 400% increase in recalls, the trend in 2010 has
continued, with the high-profile voluntary recall of over 130 million
bottles of OTC children's drugs, they add.


However, the Pharmaceutical Research and Manufacturers of America
(PhRMA) points out that the US regulatory system for prescription drugs
"is the toughest and safest in the world," but adds that it is looking
forward to reviewing Sen Bennet's bill as part of the industry's
continuing efforts, working with Congressional leaders, on ideas for
making further improvements to the safety of the national drug supply.


Brand-name pharmaceutical companies make "tremendous investments in
quality control systems and take extensive measures to help protect
patient safety and to help prevent adulterated ingredients from entering
into America's prescription drug supply. In addition, drug manufacturing
for the US market - regardless of where it occurs - is regulated under
Good Manufacturing Practices (GMP) by the FDA," said PhRMA senior vice
president Ken Johnson.


Nevertheless, Consumers Union health policy analyst William Vaughan said
he hoped Sen Bennet's bill can be approved in the remaining days of the
current Congress - "before consumers are again faced with another
Chinese-heparin-type case of death and injury from unsafe, contaminated
and corrupted drugs."


By Lynne Taylor



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