Waxman Sets Sights On Dingell’s Energy And Commerce Chair

One day after Democrats increased their number of seats in the House, Rep. Henry Waxman sent ripples across the majority with a bid to replace Rep. John Dingell as Energy and Commerce Committee chairman.

Citing his "skill and ability to build consensus and deliver legislation," Waxman announced Nov. 5 that he is seeking to head the committee as it deals with energy, climate change and health.

The California representative has been Oversight and Government Reform chairman since Democrats regained control of the House in the 2004 congressional elections.

Whether Waxman, re-elected to his 17th term Nov. 4, is successful will be decided by the Democratic steering committee and caucus during organizational meetings to be held the week of Nov. 17.

To take the Energy and Commerce chairman's post, Waxman would have to resign as Oversight and Government Reform chairman. New York Rep. Edolphus Towns is the next senior Democrat on Oversight.

Waxman chaired Energy and Commerce's then-Health and Environment Subcommittee from 1979 to 1994 and was its ranking member in 1995 and 1996. During that period he led development of the Hatch-Waxman law, which created the regulatory scheme for small molecule generics, and the Orphan Drug Act.

He could make biosimilars legislation an Energy and Commerce priority as chairman.

Waxman was an early proponent of bringing competition to the biologics market, introducing legislation in 2006 to allow FDA to approve generic biologics.

In a Nov. 6 earnings call, Barr CEO Bruce Downey acknowledged Waxman is a leader in pushing for a biogenerics pathway, but pointed out that "whether he becomes the chairman of the Commerce Committee or remains Chairman of the Oversight Committee, he will be active and a strong advocate for that legislation."

However, Waxman can do little to move a biosimilars bill forward while Dingell controls Energy and Commerce.

Dingell has not developed his own biosimilars measure, and following enactment of the FDA Amendments Act of 2007, his focus with regard to FDA has been on strengthening agency oversight of imported products, including pharmaceuticals.

The Michigan representative, who was elected in 1955 and is the longest-serving House member, circulated several iterations of an FDA Globalization Act this year (¹ (Also see "Drug Manufacturers’ Supply Options Could Be Constricted By Legislation" - Pink Sheet, 25 Aug, 2008.), p. 6).

"I will introduce this bill early next year and intend to move it through the committee with the utmost speed," Dingell pledged in a Nov. 6 letter asking members of the Democratic Caucus to re-elect him as Energy and Commerce chairman.

Dingell's globalization efforts offer an example of how he would give FDA limited discretion as part of new authorities.

One draft of his globalization bill set a biennial inspection schedule for foreign facilities because of Dingell's concern that allowing FDA to adopt a risk-based approach would permit the agency to "only do the minimum."

The latest version of Dingell's draft provides more flexibility, but continues to flag the inspection timeframe as an item for continued discussion, indicating a continued concern about the reliability of FDA's discretion.

House Speaker Nancy Pelosi is publicly staying neutral in this rare challenge of the seniority system, but speculation on Capitol Hill is Waxman would not have launched his bid without at least tacit approval from his fellow California Democrat.

Pelosi has waged proxy fights with Dingell, backing Lynn Rivers in 2002 when redistricting forced Rivers into a primary challenge against Dingell.

Waxman's move against Dingell would be his second leapfrogging gambit in committee leadership. Following the 1978 elections, he established himself as a major Washington player by - again in defiance of the seniority system - beating out then-North Carolina Rep. Richardson Preyer for chairman of a coveted subcommittee.

A Committee Divided

One idea that has been mentioned to resolve the conflict between Dingell and Waxman would be to split the committee's responsibilities' into two panels. However, the interests of Waxman - who has also sparred with Dingell on environmental issues - seem to encompass all of areas under Energy and Commerce's authority.

In any event, the committee is already divided.

Health Subcommittee Chairman Frank Pallone, D-N.J., is supporting Waxman's bid.

Dingell, however, has the support of his four other subcommittee chairmen - Bart Stupak of Michigan - oversight and investigations; Rick Boucher of Virginia - energy and air quality; Gene Green of Texas - environment and hazardous materials; and Bobby Rusk of Illinois - commerce, trade and consumer protection.

Rep. Ed Markey, chairman of the Telecommunications and Internet Subcommittee, has not yet weighed in on the matter.

As the new Congress convenes Jan. 6, the only Democrats expected to leave the committee are Darlene Hooley of Oregon who retired, and Thomas Allen, who left to pursue an unsuccessful bid for the Senate in Maine.

Republicans Barbara Cubin of Wyoming, Heather Wilson of New Mexico, and Mike Ferguson of New Jersey, all members of the Subcommittee on Health, as well as Chip Pickering of Mississippi and Vito Fossella of New York will not be returning.

Waxman Stakes Biologics Preference

In the biologics debate, among the more contentious issues is the degree to which legislators define the process and data needed for approval of follow-on products.

Waxman's bill, H.R. 1038, which is co-sponsored by Energy and Commerce/Health Subcommittee Chairman Frank Pallone, D-N.J., provides flexibility for FDA to decide what data will be required, although it does set broad guideposts for what would constitute substitutability.

In contrast, H.R. 5629 - the bill from Reps. Anna Eshoo, D.-Calif., and ranking Republican Joe Barton of Texas which continues to pick up cosponsors - is more prescriptive in terms of what data FDA must ask for as part of a follow-on approval.

- Cathy Dombrowski ([email protected])