Legislation introduced in the Senate to give FDA mandatory recall authority for all drugs would bar the agency from considering a drug's prescription status when assessing risk to prioritize inspections.

Sen. Michael Bennet's bill introduced Aug. 3, like other proposals Congress is considering to strengthen certain sectors of FDA oversight, draws from legislation introduced in 2008 that called for comprehensive enforcement reforms across the agency.

Consumer and public health advocacy groups supporting Bennet's bill say in a same-day release that FDA "has traditionally focused" its manufacturing oversight on Rx products and not OTCs.

Bennet's Drug Safety and Accountability Act of 2010, S. 3690, addresses that concern. The Colorado Democrat's bill prohibits FDA officials from considering whether a drug is OTC or Rx when deciding whether to inspect an entity based on the possible risk represented by a product.

During a media briefing with industry members and advocacy groups who support his bill, Bennet said Johnson & Johnson subsidiary McNeil Consumer Healthcare's April recall of 1,500 lots of popular children's OTCs illustrates the importance of regulatory oversight of OTC drug manufacturing.

"Over-the-counter medicine is taken by Americans every day and should not receive less oversight, as we learned from the children's Tylenol recall," Bennet said.

Representatives from the Pew Prescription Project, the American College of Physicians, the Society of Chemical Manufacturers of America and consumer health care organization Community Catalyst joined Bennet in the briefing. The American Association of Retired Persons and the Consumers Union also support the bill, according to a joint release.

Brant Zell, chairman of SCMA's Bulk Pharmaceutical Task Force and a VP at Cherokee Pharmaceuticals, said foreign OTC manufacturers that export products to the U.S. currently have an advantage over domestic firms.

"Today, foreign OTC sites, most of them have not even been inspected and there's no mandate to inspect foreign OTC sites," Zell said. "Manufacturers from India and China are not under the same controls. I think the risks are clear in this point."

Pew also released the results of a poll showing broad support among U.S. consumers for increased regulation of Rx drugs and growing distrust of products manufactured in India and China. The group's Prescription Project advocates reforms in the regulation, manufacturing and marketing of Rx drugs.

The bill also would allow FDA to engage in mutual regulatory agreements with other countries' oversight bodies and explicitly allow the agency access to overseas plants making drugs intended for U.S. markets.

Confidential Information Can Be Shared

Additionally, the bill would authorize FDA to assess civil penalties for regulatory violations and subpoena witnesses and documents. Bennet's legislation also would protect whistleblowers who alert FDA to drug safety problems.

The bill also addresses industry's role. S. 3690 mandates that drug companies create quality management plans that document every step of manufacturing processes and require that firms allow FDA to inspect the plans.

In one potentially controversial provision, the bill permits FDA to disclose drug manufacturers' confidential information to other government agencies. Potential recipients of the information are federal, state and local agencies, regulatory units of foreign governments and international organizations established to facilitate harmonization of standards or to coordinate public health efforts.

Disclosure of confidential information to other parties, including individuals, also would be permitted when FDA determines it is needed to protect the public health, unless prohibited by other laws.

More Narrowly Focused FDA Reforms

The proposal follows a similar bill Rep. Edolphus Towns, D-N.Y., recently introduced to authorize FDA to mandate recalls of misbranded, adulterated or potentially unsafe drugs (¹ 'The Tan Sheet' July 19, 2010, In Brief).

Portions of Bennet's and Towns' bills reflect provisions of legislation the late Sen. Ted Kennedy, D-Mass., and Rep. John Dingell, D-Mich., introduced in 2008 (² Also see "Senate Bill Adds Criminal Liability To Global Drug Safety Enforcement" - Pink Sheet, 11 August, 2008.).

Both bills called for sweeping changes in FDA's enforcement over foods, drugs and medical devices, including mandatory recall power for all drugs.

Kennedy's bill imposed user fees to pay for drug facility inspections and required a senior drug executive to personally certify the veracity of product applications and safety submissions. Dingell included a provision in his bill to impose inspection fees on imports.

Possibly due to the expansive nature of the bills, neither has gained traction.

However, like Bennet's and Towns' bills addressing FDA authority over drug manufacturing, food safety enforcement reform bills in both chambers largely carve out components of Dingell's and Kennedy's 2008 bills (³ 'Health News Daily' Nov. 19, 2009).

"We cannot and we should not wait for the next crisis to fix a broken regulatory system that allows unsafe drugs to enter U.S. homes," Bennet said.

Bennet spokesman Adam Bozzi said the senator expects the bill to pass this session. "This is a consumer protection bill that affects families across the country," he wrote in an e-mail. "We'll look for bipartisan support and then to get a vote on it."

Bennet, a member of the Committee on Health, Education, Labor and Pensions, which has jurisdiction over FDA, is up for re-election in November.

The Consumer Healthcare Products Association is reviewing the legislation, a spokeswoman said.

Congressional Attention Could Be Stretched

The Senate left for recess Aug. 6. The House broke for recess on July 30, though majority party leaders called members back for an Aug. 9-10 session on an education and Medicaid bills.

Following the House mini-session, neither body returns from recess until after Labor Day, when most legislative time likely will go to fiscal 2011 appropriation bills. The federal fiscal year begins Oct. 1.

The attention of all House and some Senate members also likely will be more on the fall elections than on legislation not considered crucial. No co-sponsors had signed on to S. 3690 before this article's publication.

- Carolyn B. Phenicie ( ⁴ c.phenicie@elsevier.com )

Senate Bill Expands FDA's OTC Manufacturing Oversight

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