New Bill Proposes to Strengthens Government Authority over Pharma Supply Chain

Society of Chemical Manufacturers welcomes closer inspection of active drug ingredients manufactured overseas

The Drug Safety and Accountability Act of 2010 was introduced on August 3 by Michael Bennet, U.S. Senator for Colorado. "Making sure pharmaceutical drugs meet the highest standards for safety and quality is important to me, not only as a U.S. Senator, but as the father of three little girls as well," said Bennet. "For too long, the FDA has lacked the proper authority to adequately safeguard our drug supply and protect Colorado consumers. It's time Washington took action to ensure the medicines Coloradans rely on are safe, and that those entrusted with the responsibility of developing these drugs are equipped to keep consumers out of harms way."

One of the reasons for the increased scruity of the quality of the medicine is due to the record 1,742 drug recalls in 2009 which is a 400% increase from the prior year.

And the emphasis on foreign production is due to the fact that up to 80% of the active ingredients in U.S. drugs are now made overseas, many in countries where regulatory oversight does not meet U.S. standards, according to the Senator.

A contributing factor to closer inspection of the supply chain is reflected by a Pew Prescription Project poll released on August 3 in which 70% of respondents reported having little or no confidence that drugs manufactured in China are free from contamination and safe for Americans. Fifty-four percent of respondents expressed the same concern about drugs manufactured in India. Ninety-four percent of Americans favor giving FDA recall authority for drugs.

The Society of Chemical Manufacturers and Affiliates (SOCMA), supported the bill. "SOCMA thanks Senator Bennet for introducing this common sense legislation which will strengthen the FDA and increase public health and safety by providing additional quality controls on drugs and their ingredients," said BPTF Chairman Brant Zell of Cherokee Pharmaceutical. "Today, about 80% of active drug ingredients come from overseas -- the majority from India and China -- yet receive less than 5% of FDA's resources. This bill is a good starting point in giving the FDA more authority, tools and resources to help ensure a safer U.S. drug supply."

Zell said the lack of FDA inspections at foreign facilities, authority, resources and management has led to significant risks to the nation's medicines. While U.S. manufacturers face strong FDA oversight and enforcement, their counterparts in India and China have little or no oversight from the FDA or a comparable agency, creating a difficult and unfair situation for American companies.

The Pharmaceutical Research and Manufacturers of America (PhRMA) pointed out the overall safety of the supply chain. "Drug manufacturing for the U.S. market -- regardless of where it occurs -- is regulated under Good Manufacturing Practices (GMP) by the FDA, " said PhRMA Senior Vice President Ken Johnson "These GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the U.S. prescription drug supply.

"PhRMA and its member companies have been working with Congressional leaders over the last several years on ideas for making further improvements to the safety of our drug supply. We look forward to reviewing U.S. Sen. Michael Bennet's bill closely as part of that continuing effort."

The bill would provide stronger tools to investigate threats to drug quality and safety such as:

*Granting the FDA the authority to assess civil penalties for violations of the Food, Drug and Cosmetic Act and to subpoena documents and witnesses

*Facilitating exchange of information between the FDA and other regulatory agencies

*Protecting industry whistleblowers that wish to bring information to the FDA.

And to boost manufacturer standards the bill would:

*Require companies to institute quality management plans to ensure the quality and safety of their drugs and drug components, including strong supplier oversight

*Ensure companies are able to document which entities are involved in the manufacturing supply chain for their drugs.

*The bill would also provide new oversight of over-the-counter (OTC) drugs. FDA has traditionally focused oversight on manufacturers of prescription drugs rather than manufacturers OTC products. The bill would prevent FDA from relegating OTC drugs to a lower-risk category for site inspection simply because of their status.

*Moreover, current FDA tracking systems for manufacturing sites contain data errors and duplicate entries, and the Government Accountability Office (GAO) has found that multiple tracking systems are not interoperable, preventing meaningful data comparison that could help the agency better target its oversight. To improve tracking and risk assessment tools, the bill would require FDA to establish accurate, interoperable information systems to track all plants making drugs and active ingredients for the U.S.," Bennet pointed out.

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