May 1, 2009
The Drug and Device Accountability Act of 2009
 
On April 23, 2009, Senators Charles Grassley and Ted Kennedy introduced bipartisan legislation in the Senate to augment the resources of the Food and Drug Administration (“FDA”) in inspecting U.S. and foreign manufacturers of prescription drugs and medical devices. Senator Grassley is the Ranking Member of the Senate Committee on Finance and has conducted oversight of the FDA’s performance. Senator Kennedy is the Chairman of the Senate Committee on Health, Education, Labor and Pensions with responsibility for FDA legislation.

An increasing number of drugs and active pharmaceutical ingredients used by Americans are manufactured in China and India. By way of introducing the bill, Senator Grassley emphasized the need to strengthen the FDA’s program for inspections of foreign pharmaceutical manufacturing plants:
 
“According to the FDA, from fiscal year 2002 through fiscal year 2007, the agency conducted fewer than 1,400 inspections of foreign pharmaceutical facilities. And these inspections were often conducted in countries with few reported quality concerns. In China, the world’s largest producer of active pharmaceutical ingredients, and where we have seen increasing reports of contaminated products, only 11 inspections were conducted during FY 2007—that is way too few.”

The Drug and Device Accountability Act of 2009 will amend the Federal Food, Drug, and Cosmetic Act to deem a drug or device to be misbranded unless certain conditions related to registration of establishments, identification of prior transactions, labeling for country of manufacture, and provision of required information on importation are met. The bill encompasses enhanced registration and inspection of drugs and devices, ensuring the identity and sourcing of drug ingredients, ensuring standards for imported drugs, heightened response to unsafe drugs, and requires certifications of information contained in applications for drugs and devices requiring FDA approval. It also directs the Secretary of Health and Human Services to establish and maintain dedicated inspectors of foreign facilities.
 
In essence, the proposed legislation expands the FDA’s authority and provides new subpoena powers to inspect manufacturers and ensure the safety of drugs and medical devices made in the U.S. and foreign countries. The Act establishes civil and criminal penalties for false and misleading certifications and includes whistleblower protections.  
 
Collection of inspection fees under the Act are intended to provide additional resources to the FDA in fulfilling its mandate to protect the pharmaceutical and food supply chains from contamination. These additional fees will be imposed on drug and device manufacturers, along with the increased cost of compliance with the new certification requirements.

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