Washington Editor

WASHINGTON - Wide-ranging FDA legislation is scheduled for Senate review on Wednesday, but notably, the bill does not include a provision related to follow-on biologics.

Called the "Food and Drug Administration Revitalization Act," or S. 1082, it includes language to reauthorize the Prescription Drug User Fee Act (PDUFA), along with new safety regulations related to risk evaluation mitigation strategies (REMS), the establishment of a nonprofit foundation to advance product development and enhance safety, requirements on clinical trial registries, restrictions on FDA advisory committee members, the renewal of medical device user fees and a provision related to pediatric exclusivity. In essence, the bill folds a number of FDA-related items into a single legislative to-do list.

All those pieces will be covered during an executive session of the Health, Education, Labor and Pensions Committee, which oversees the agency. Such comprehensive action has been widely expected for months, since past hearings on PDUFA have signaled the panel's interest in building a broad legislative package. The current PDUFA legislation expires at the end of the government fiscal year on Sept. 30,

The basis for S. 1082's safety language comes primarily from Sens. Edward Kennedy's (D-Mass.) and Mike Enzi's (R-Wyo.), S. 484. Kennedy serves as the HELP Committee's chairman, and Enzi its ranking member.

It's significant, though, that S. 1082 has no language on creating abbreviated approvals for follow-on biologics. That issue has sometimes come up in the context of pending FDA legislation, since it generally is considered important to certain lawmakers looking to curb rising health care costs. Just last week, nearly two dozen governors sent a letter to congressional leaders calling for members to act this year on a follow-on biologics bill.

In addition to the HELP Committee's session, a hearing on PDUFA's renewal has been scheduled for Tuesday by the health subcommittee of the House Energy and Commerce panel, which also has FDA oversight authority.

As in the Senate, many House members have indicated their desire to merge the reauthorization process with efforts to improve the FDA's safety regulations.

Two congressmen who sit on the Energy and Commerce Committee, Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.), have introduced a safety bill in the lower chamber designated H.R. 1561.

A witness list for the health subcommittee hearing was not available as of press time. Final action on PDUFA is expected well ahead of Sept. 30 to avoid personnel problems for the FDA.

Senate To Vote On Part D Changes

The Senate is scheduled to vote today on a bill that would allow the federal government to negotiate drug prices for products covered under Part D of Medicare by striking a non-interference clause in the existing law, the Medicare Modernization Act of 2003.

Last week, the Finance Committee approved language in the measure, the "Medicare Prescription Drug Price Negotiation Act of 2007," or S. 3. However, it's not written as strictly as its House counterpart, H.R. 4, which mandates government negotiations on Part D drugs. That bill passed early this year.

At present, private insurers negotiate Part D drug prices with manufacturers, absent government involvement.

There remains opposition beyond the halls of congress, though. Mike Leavitt, secretary of the Department of Health and Human Services, recently reiterated his distaste for the legislation. In the past, he has said government negotiations on Part D drugs represent a step toward government-run health care.

In addition, the drug industry continued to issue statements of opposition.

In a letter to Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Member Chuck Grassley (R-Iowa), BIO President and CEO Jim Greenwood cautioned that the legislation "would ultimately restrict access" to therapies and limit patient choices because the government would make one-size-fits-all coverage decisions. He also warned that another provision in the bill, related to comparative effectiveness studies, should not be "used as a means to contain costs and restrict access."

Panel Rejects COX-2 Drug Arcoxia

The FDA's Arthritis Advisory Committee last week voted overwhelmingly against Merck & Co. Inc.'s application to market another COX-2 inhibitor in the U.S., Arcoxia (etoricoxib).

The 20-1 decision was based on general worries about that class of drug, to which Vioxx (rofecoxib) belongs. In news related to that product, which was pulled off the market two and a half years ago by the Whitehouse Station, N.J.-based company, word has surfaced that 1,000 lawsuits against Merck will soon be dismissed. That news, in addition to the dismissal of a securities class action suit against the company and its upward revision of earnings forecasts, boosted its stock (NYSE:MRK) on Friday by 8.3 percent, or $3.85, to close at $50.21.

Final FDA action on Arcoxia, which is marketed in 63 other countries around the world, is expected by April 27.

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