Washington Editor

WASHINGTON - More than two years after the enactment of the FDA Amendments Act of 2007 (FDAAA), which gave the agency new authorities and funding, drug regulators have made progress but remain challenged in protecting Americans, Joshua Sharfstein, principal deputy commissioner told lawmakers last week.

Given that diethylene glycol - the chemical that spurred the creation of the FD&C Act of 1938 - and other contaminants continue to be found in medicines, the FDA's work is "far from done," Sharfstein said Wednesday during testimony before the House Energy & Commerce Subcommittee on Health.

Rep. Henry Waxman (D-Calif.), the committee's chairman, noted that it had been several months since his panel focused on drug safety, but "that pause does not represent any lessening of our collective commitment to this issue."

While Congress made some "major strides" in passing FDAAA, "there is much work to be done in the area of drug safety," Waxman insisted.

Sharfstein pointed to globalization as the source of many of the FDA's challenges in ensuring the safety of the U.S. drug supply. Up to 40 percent of the medications sold in the U.S. are imported, and up to 80 percent of the active pharmaceutical ingredients in all medicines are from foreign sources, he said.

"We need to place a greater onus on all manufacturers to oversee the safety of their own products," Waxman demanded.

Sharfstein assured lawmakers that the FDA has been moving from reacting to problems created by globalization, such as the increase in counterfeit drugs and contaminated medicines, to "proactively" preventing those activities "at every point along the global supply chain."

He noted that the FDA now has permanent offices in China, India, Costa Rica, Mexico and Chile and will soon have an office in Amman, Jordan, and has more than 30 agreements with foreign regulators to share inspection reports and other nonpublic information.

The FDA also has been working with the industry to help drug and biologic makers strengthen the safety of their supply chains, he added. "Some companies already do a terrific job at this, tracking where and how their products and their components are made and the path taken to reach our shores," Sharfstein said.

During Wednesday's hearing, Sharfstein also noted that under the FDAAA authorities, regulators have required about 200 postmarketing studies and have mandated safety labeling changes in individual or classes of drugs 32 times.

Diabetes, Cholesterol Drugs Top Spending

Medications to treat high cholesterol and diabetes are the leaders when it comes to Medicare drug spending, according to a new report from the Agency for Healthcare Research and Quality (AHRQ).

In 2007, the most recent year for which data are available, purchases of cholesterol and diabetes prescription drugs by elderly Medicare beneficiaries reached nearly $19 billion, or about one-fourth of the $82 billion spent for medications for seniors, AHRQ reported last week.

Seniors spent $15 billion on cardiovascular drugs, $8 billion for drugs to treat central nervous system conditions and $7 billion on gastrointestinal medicines.

Spending on hormones to treat osteoporosis, cancer and other conditions was about $5 billion, AHRQ said.

PhRMA Proposes Social Network Universal Symbol

The FDA should adopt a prominent universal symbol that would in a single click go directly to agency-regulated risk information to ensure online readers and social media users can distinguish legitimate information from gossip, the Pharmaceutical Research and Manufacturers of America (PhRMA) proposed last week.

The use of the FDA's own logo or another agency-approved symbol would "shine a brighter spotlight" on official websites of U.S.-approved medical products containing reliable and comprehensive information about benefits and risks, Jeffrey Francer, PhRMA's assistant general counsel, told reporters last Tuesday.

PhRMA's suggestion was made in response to a request for comments from the FDA about regulating drug information in the social media world of Twitter, Facebook and YouTube. The FDA last November held a two-day meeting on the topic to seek input from various stakeholders. (See BioWorld Today, Nov. 13, 2009.)

Francer said the FDA also should permit drugmakers to present brief introductions to health information in an electronic format, allow manufacturers to "serve as responsible stewards of newsworthy information" and "permit companies to microblog about significant scientific and regulatory events."

Sebelius Confronts Health Insurers

Health and Human Services Secretary Kathleen Sebelius last week confronted the insurance industry head-on about its multimillion-dollar spending on antireform efforts and Washington lobbyists.

Rather than using the millions of dollars insurers have made from Americans' premiums to kill the reform legislation, the industry could "start giving Americans some relief," Sebelius charged during a speech at a conference held by America's Health Insurance Plans, the industry's trade group. "Instead of spending your energy attacking the parts of the president's proposal you don't like, you can use it to strengthen the parts you do," she said.

Obama Expands Recapture Audit Program

President Obama last week expanded the use of private-sector auditors to investigate and reclaim taxpayer dollars lost in error or from fraud and abuse in federal health programs.

The so-called recapture auditors are compensated based on the amount of improper payments they identify and those that are reclaimed, which the White House said provides a "powerful incentive to find every error."

The recapture program is being expanded from a pilot program run by Medicare in California, New York and Texas, which recouped $900 million from 2005 to 2008. The White House said the expanded recapture program is expected to recoup at least $2 billion over the next three years.

Collins Awarded Albany Prize

National Institutes of Health Director Francis Collins last week was named a recipient of the Albany Medical Center Prize in Medicine and Biomedical Research for his leading role in mapping the human genome.

But Collins had to decline his portion of the $500,000 prize to comply with government ethics rules. The Albany Medical Center Prize is often called "America's Nobel."

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