Consumer Survey Highlighting Drug-Safety Worries Accompanies Introduction of

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Pharmaceutical CommercePharmaceutical Commerce - September/October 2010

Senator Michael Bennet wants better FDA oversight of drug supply chain and material sourcing, as survey shows that 36% of Americans likely to vote have heard of unsafe ingredients

Maximizing media coverage, the US senator introduces his bill on the same day that the Pew Prescription Project (Boston) releases a recent poll showing rising consumer concern over drug quality and FDA oversight of non-US manufacturing sites. AARP, the American College of Physicians, Consumers Union and other interest groups signed on as supporters of the legislation.

SEN. MICHAEL BENNET

Bennet notes that there were a record 1,742 drug recalls in 2009—a 400% increase from the previous year. While much of this is more-aggressive enforcement by FDA, there has been a worrisome increase in quality-control problems, most notably the OTC products recalled by J&J’s Ortho McNeil unit since the beginning of this year. Meanwhile, there continue to be repercussions from the heparin scandal of 2008, when it was found that adulterated heparin raw material had been imported from China, made into finished product by, among others, Baxter International, and caused the deaths of an estimated 149 Americans. Minority members of the Energy and Commerce Committee, Joe Barton and Michael Burgess, have sent letters to FDA Commissioner Margaret Hamburg pushing for a more thorough investigation of that incident, just as she was preparing for a trip to China this month.

Bennet’s bill does not seem to contain any extraordinary new regulation of the industry, but calls for better management of existing FDA authority. Key elements include:

  • better documentation of where APIs and manufactured products come from;
  • requiring more testing of ingredients at FDA request;
  • subpoena ability for quality or manufacturing documents;
  • mandatory recall authority and the ability to assess civil penalties.

The bill also calls for use of the D-U-N-S (Dun & Bradstreet) numbering system for identifying manufacturing sites and—in what seems to be a slap in the face of Chinese manufacturers, who have a habit of changing company names and locations—use of GPS coordinates. But what might be the most far-reaching change is to require FDA to review OTC product supply chains as closely as it does for prescription products, by requiring FDA to make risk assessments independently of a drug’s prescribing status.

Growing suspicion over imports

The Pew Prescription Project (PPP; Washington, DC; a part of The Pew Charitable Trusts) has released a survey showing that more than a third of American “likely to vote” (take heed, Washington!) have heard about drug-quality problems, and of those, a majority (60%) believe that FDA should be doing more about it. In supporting the Bennet legislation, Allan Coukell, director of PPP, said that “This bill will help to protect the drug supply chain by strengthening manufacturing quality standards throughout the pharmaceutical industry, which is critical as drug companies increasingly rely on contractors in countries where regulatory standards may be lower than those in the United States.”

The PPP survey shows some well-informed consumers on drug sourcing and quality: while 78% are “extremely/mostly confident” of US manufacturing quality, the percentage goes down to 8% for India and 6% for China. Overall, 58% of respondents “strongly” support the Bennet legislation, and 31% “somewhat” support it. In addition, 73% “strongly” favor unique IDs on individual drug packages, and 72% “strongly” favor listing ingredient origin on the drug label.

“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,” Bennet said in a press release.

Ken Johnson, SVP at PhRMA, issued a statement saying : . 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,” and that PhRMA has been working with Congress on further safety improvements.

All this is occurring as Senate committee staffers continue to work on re-introducing the Buyer-Matheson legislation from 2008, which more or less followed the structure of the California e-pedigree legislation that was put on hold in that year. With a national election looming in November, it looks doubtful that the bill will be introduced in this Congress, especially in the aftermath of the rancorous healthcare-reform debate. But it’s easy to envision the Buyer-Matheson requirements for drug track-and-trace systems being combined with Bennet’s supply-chain security measures. PC

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