United States: Proposed House Bill Could Enact Sweeping Changes to Drug Safety Laws

Sponsors of recently proposed legislation intend to equip the U.S. Food and Drug Administration (FDA) with the additional authority and funding needed to increase monitoring and enforcement of safety measures for drugs and drug ingredients that are manufactured outside of the United States.  With up to 80 percent of the United States' active drug ingredients originating overseas, the bill poses sweeping changes to drug safety laws.

H.R. 6543, entitled the Drug Safety Enhancement Act of 2011, was introduced on December 17, 2010, by Rep. John D. Dingell (D-MI), Chairman Emeritus of the Energy and Commerce Committee, Rep. Henry A. Waxman (D-CA), Chairman of the Energy and Commerce Committee, Rep. Frank Pallone (D-N.J.), Chairman of the Subcommittee on Health, and Rep. Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations.

The legislation echoes the Drug Safety and Accountability Act of 2010, introduced by Sen. Michael Bennet (D-CO) on August 3, 2010, and builds on H.R. 759, the Food and Drug Globalization Act, introduced by Dingell, Pallone and Stupak last year, reflecting the growing concern over issues related to globalized drug supply chains.

The bill was prompted in part by 80 deaths in 2008 that have been linked to heparin contaminated in the manufacturing process in China.  The bill's sponsors assert the contamination is a prime example of the threats posed by the globalization of drug supplies.  According to the sponsors, there was a record-setting 1,742 drug recalls in 2009, most of which stemmed from manufacturing quality or testing issues.

Similar to the Bennet bill, H.R. 6543 seeks to provide FDA with greater monitoring and enforcement power at home and abroad, in addition to funding for the expanded role, in four key areas:

Prevention

The bill proposes a multi-prong approach to preventing future drug safety issues.  Measures include creation of a registry of all domestic and international drug facilities, good manufacturing practices inspections of facilities, with parity required between the inspections in the United States and abroad, and a prohibition against delaying, limiting, or refusing inspection.  FDA would have the authority to issue cease-distribution orders and recall orders for suspected adulterated drugs or drug supplies. 

Drug manufacturers would be required to implement an effective quality system, including the provision of adequate resources to maintain a good manufacturing practice, periodic reviews, timely communication plans, and proper recordkeeping of the data, records, and regulatory submissions.

Response

The bill would give FDA additional power to penalize non-compliant drug companies, with authority to impose civil penalties of up to $500,000 for each violation, with a maximum cap of $10,000,000for all such violations adjudicated in a single proceeding, as well as stiffer criminal penalties.

Importation and Exportation

The Secretary would have the authority to require safety documentation or other information for a drug that is being imported into the United States, with refusal of admission for any non-compliant product. 

Miscellaneous Additional Protections

The bill would require the assignment of unique identification numbers for establishments, importers, and customs brokers, to enable easier tracing of potential contamination sources.  FDA would have the authority to subpoena records related to possible violations.

Under the bill, a manufacturer of a finished drug product would be required to list on its website both the country of origin for each active pharmaceutical ingredient and the place of manufacture of the finished dosage form of the drug.  Additionally, companies would be prohibited from submitting false or misleading reports to FDA, and whistleblowers would be given new legal protection for reporting potential violations of the act and for refusing to participate in violations.

A similar bill, the Drug and Device Accountability Act of 2009, proposed by Senators Ted Kennedy and Chuck Grassley, stalled in the Committee on Health, Education, Labor, and Pensions.  But amid the increasing concern over globalization-related drug safety issues, and with the 111th Congress winding down, the sponsors of H.R. 6543 and Sen. Bennett remain committed to an overhaul of global drug safety measures.  Bennet reportedly plans to re-introduce his bill next year in the new Congress, and the H.R. 6543 sponsors plan to use their proposed legislation as a discussion springboard when the 112th Congress convenes.

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