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 survey.
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 tank.
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 Catalyst.
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.”