The House followed the Senate July 11 in passing "FDA Revitalization" legislation calling for greater access to more medicines and strengthening the agency's post-marketing authority.

Among other provisions, the bill allows FDA to mandate risk management plans, which could boost agency authority to set behind-the-counter sale and other restrictions as conditions of approval for some nonprescription switches.

The primary focus of H.R. 2900, approved by a margin of 403-16, is renewing both FDA's device and drug user fee programs.

However, the bill also contains provisions relating to agency oversight of drug safety, pediatric product development and clinical trial registration, among others.

Ten Democrats and six Republicans voted against the measure. The Senate bill passed May 9 in a 93-1 vote, with Bernard Sanders, I-Vt., voting against it.

The House and Senate will initiate a conference to reconcile the bills "ASAP," according to a House staffer close to the matter. Individual members participating in the conference committee had not yet been named as of July 13.

The user fee program expires Sept. 30, but Congress would have to reauthorize it before going on a month-long recess in August in order to prevent FDA from having to prepare for the eventuality of budget cuts that would result from the loss of user fee revenue.

The most contentious issues expected to be on the table in conference primarily involve pharmaceutical oversight, with the question of whether to establish a legal abbreviated path for "follow-on" biologic therapies (on a parallel with generic drugs) near the top of the list.

Discussion of whether FDA has authority to assign drugs to third class status has increased since Commissioner Andrew von Eschenbach announced in March the agency would explore behind-the-counter sales and other options for prescription therapies that could provide a benefit in wider distribution but may not qualify for traditional OTC sales (¹ Also see "Von Eschenbach Promotes Behind-The-Counter Drug Class" - Pink Sheet, 19 March, 2007., p. 3).

At a drug industry conference in June, former FDA Deputy Commissioner Scott Gottlieb said both FDA Revitalization bills would give the agency "explicit authority to impose risk-management plans" when approving applications, including switches (² Also see "Risk Management Could Bolster FDA Behind-The-Counter Switches – Gottlieb" - Pink Sheet, 2 July, 2007., p. 3).

Gottlieb, who returned to the American Enterprise Institute in January, said the bills' risk-management language, while not explicit to OTC switches, would allow FDA to mandate behind-the-counter sales as part of a risk management plan.

The Consumer Healthcare Products Association says it does not expect having "greater authority to impose restrictions of drug distribution" to lead FDA to assign nonprescription products to behind-the-counter sales.

"We don't expect particularly different outcomes from current practice, under which FDA and applicants can already reach agreement on appropriate distribution for specific OTC drugs," CHPA says.

According to a House Energy Commerce Committee report, H.R. 2900 would authorize FDA to impose risk-management plans on drugs when it determines the products "can be safely used only if distribution or use of such drug is restricted." The restrictions, however, must "minimize the burden on the health care delivery system" but "not be unduly burdensome on patient access to the drug," the report says.

In the risk-management plans, FDA is authorized to require systems through which firms "monitor and evaluate the implementation of the restrictions" and determine how to improve the effectiveness of the plans.

In addition, H.R. 2900 states when health care facilities "have failed to meet their responsibilities for implementing the restrictions" from products' risk-management plans, FDA would stop those facilities from distributing the drugs for which they are found to be in noncompliance.

FDA's approval for Barr's Plan B OTC emergency contraception came after the sponsor volunteered a risk-management plan, the Convenient Access Responsible Education program, which outlines distribution, education and monitoring of sales (³ Also see "Plan B Pioneers OTC “Pharmacy Counter” Approval, Dual-Status Marketing" - Pink Sheet, 28 August, 2006., p. 3).

- Malcolm Spicer (m.spicer@elsevier.com) and David Filmore (d.filmore@elsevier.com) "The Gray Sheet"

FDA Revitalization Bill Clears House, Heads For Conference

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