Consumer Protection: Expect Action On Product, Drug Safety

Growing concerns about the quality and safety of prescription drugs will likely trigger hearings in both the House and the Senate this year. Leaders in both chambers have pledged to overhaul drug safety policies at the Food & Drug Administration.

“We need better protections against unsafe drugs and stronger oversight of the entire drug supply chain,” Sen. Tom Harkin (D-Iowa), chairman of the Health, Education, Labor & Pensions Committee, said in a joint statement with Sen. Michael F. Bennet (D-Colo.) last month. Both senators vowed to work with leaders in the House to pass a drug safety bill during this Congress.

To get the ball rolling, Bennet plans to reintroduce the Drug Safety & Accountability Act early this year. The bill (S. 3690), which failed to move in the last Congress, would strengthen drug manufacturing quality standards and improve tracking of drugs manufactured at foreign sites. It would also give FDA authority to recall unsafe drugs and beef up the agency’s enforcement ­powers.

In the House, action will be spearheaded by Rep. John D. Dingell (D-Mich.), who introduced the Drug Safety Enhancement Act (H.R. 6543) during the waning days of the previous Congress as a prelude to his intentions in this Congress. Harkin and Bennet praised this legislation, which, like Bennet’s bill, would give FDA more authority and resources to regulate a more globalized drug market.

Dingell is expected to reintroduce the bill this year. “Americans have been constantly reminded over the years of the challenges FDA and the industry face in ensuring the safety of the U.S. drug supply,” he said in a statement. “We must address the deficiencies that have been uncovered by recent recalls.” Dingell has promised to work with colleagues on both sides of the aisle to get the bill moving as quickly as possible.

Rep. Darrell E. Issa (R-Calif.), chairman of the House Committee on Oversight & Government Reform, has also announced plans to investigate the failure of FDA to keep the U.S. drug supply safe. Within the next three months, Issa plans to hold a hearing to shed light on FDA failures, with the purpose of reforming the agency and making it more transparent and accountable to the public.

As the U.S. grapples with growing concerns about the quality and safety of drugs, it is also facing increasing shortages of many lifesaving drugs. Sen. Amy Klobuchar (D-Minn.) intends to address that problem by introducing new legislation this month. The bill would require pharmaceutical companies to notify FDA in advance when they decide to limit or discontinue making a particular drug. It would also give FDA the authority to expedite approval of alternative treatments or allow the importation of equivalent drugs from other countries.

Last month, Klobuchar sent a letter to FDA Commissioner Margaret A. Hamburg urging FDA to take “immediate action” to ensure the availability of essential drugs. She pointed out that numerous medications are in short supply, including morphine for pain relief, propofol for sedation, and leucovorin for treating cancer.

“Physicians, pharmacists, and patients are currently among the last to know when an essential drug will no longer be available,” Klobuchar said in a statement. “There needs to be better coordination between the pharmaceutical industry, FDA, and health care providers so patients don’t lose access to the medications they depend on.”

Access to key cancer drugs is also on the agenda for the House Energy & Commerce Committee. Chairman Fred Upton (R-Mich.) and other Republicans on the committee were “gravely concerned” by FDA’s decision last month to withdraw approval for Avastin to treat breast cancer because the agency found the drug to be unsafe and not effective for that use (C&EN, Dec. 20, 2010, page 23). In a joint statement, they claimed that “FDA is putting economics ahead of proper courses of treatment.” FDA’s decision to deny access to Avastin “is the first step towards government rationing of health care,” the lawmakers said.

Upton and his Republican colleagues vowed “strict FDA oversight” during this Congress, saying the Avastin decision was “just the beginning” of more to come under the health care reform law. “The Energy & Commerce Committee is committed to repealing the new health care law, and we will hold hearings to hold FDA accountable for its decision and protect access to treatment for the thousands of women who rely on this drug,” the lawmakers added.

Product safety will also be on the docket for the House Energy & Commerce Committee. Specifically, the committee is expected to take another look at the two-year-old Consumer Product Safety Improvement Act. Pushed by the chairman of the committee at the time, Rep. Henry A. Waxman (D-Calif.), the law particularly vexed manufacturers and sellers because it set a standard for lead content in all children’s products that was nearly impossible to meet.

Both Democrats and Republicans on product safety subcommittees of the House Energy & Commerce Committee and the Senate Commerce, Science & Transportation Committee have indicated they would like to review the lead standard section of the legislation, possibly giving the Consumer Product Safety Commission more flexibility on regulating some products.

CPSC Chairwoman Inez M. Tenenbaum has said she favors reexamination of parts of the law. The agency has put on hold some of the law’s provisions for product testing and certification because of alarms raised by small businesses over the cost of implementing the lead standard.