The legislation to renew the pediatric exclusivity language in the House now provides six months for all products as opposed to the sales-tiered incentives in the Senate bill, but the more generous offer serves to underline the challenge to the program - finding an offset to pay for it.

Under the new congressional "pay go" spending rules, any legislation that induces federal spending must be accompanied by an equivalent offset in order to pay for it. The pediatric exclusivity program falls under the rule because the longer brand life it creates raises costs for federal health programs including Medicare and Medicaid.

The challenge for sponsors of a "straight" renewal of the pediatric exclusivity program is to: (a) ensure that the House, not the Senate, version of the legislation is agreed to in conference, and (b) identify reductions in spending so that the measure can be enacted.

The amount of spending triggered by the program, while not profound, is significant. The Congressional Budget Office "has informally estimated that a straight reauthorization of current law would cost approximately $200 million over 10 years, and that the three-month limit for blockbuster drugs would reduce that amount by approximately $50 million," a House Energy and Commerce Committee briefing document states.

Finding An Offset At FDA

At the Health Subcommittee markup June 19, Chairman Frank Pallone, D-N.J., said that one possible offset would be provisions that would reform the citizen petition process, thereby allowing quicker generic entry and lowering federal health spending.

"I know there are concerns from the minority about including that language in this setting, but I must say that we have to come up with a 'pay for' if we want to reauthorize this program," Pallone said. The bill could reach the House floor as soon as June 28, and might be brought up under the "suspension calendar," which would allow it to skirt the budget rules.

The Senate version of the bill includes language to limit citizen petitions that was adopted in conjunction with measures to encourage development of antibiotics and to clarify how FDA should handle enantiomers for drug approval purposes (¹ [A#00690190002], p. 4).

As part of the renewal of the pediatric exclusivity program in the Senate, the standard six-month exclusivity is changed to three months for "blockbuster" products with more than $1 billion in annual sales. Supporters of the cap defeated attempts in committee and on the floor by Sen. Wayne Allard, R-Colo., that would have restored the six months (² Also see "Rx Safety Bill Produces Restless REMS; Core Of “KEnzi” Is Narrowed But Intact" - Pink Sheet, 23 April, 2007., p. 3).

For the House version, Pallone had crafted language that would allow FDA to establish criteria that would award exclusivities between three and six months based on a variety of factors. Pallone described the section as a compromise, but Rep. Anna Eshoo, D-Calif., sponsored an amendment that stripped the provision, restoring six months of exclusivity for all products. Seven Democrats joined the Republicans in modifying the bill.

A House And Senate Divided

The length of exclusivity will now need to be resolved in conference with the Senate. House Democrats' support for the straight six months and the close votes in the Senate suggest the three-month cap may be abandoned in the final version of the bill.

There are several other differences between the House and Senate versions of the pediatric legislation, most notably that the House version permanently reauthorizes the Pediatric Research Equity Act, which gives FDA authority to require studies in children. The Senate version had originally included the permanent reauthorization, but a sunset was restored so that both the study authority and study incentive would expire in 2012.

Republicans had argued that the provisions serve as carrot and stick and need to be reauthorized in tandem - either permanently or episodically. Supporters of a permanent PREA authorization say that FDA's power over pediatric products should be the same as it is over adult drugs.

The full committee markup on June 21 saw an attempt by Rep. Bart Stupak, D-Mich., to require that exclusivity be contingent on labeling changes, not just satisfactory completion of studies. Stupak withdrew the amendment after leadership said it was outside the scope of the negotiated bill.

The House bill also extends the amount of time that FDA has to make a determination on pediatric exclusivity (³ Also see "Pediatric Exclusivity 90-Day Review Can Be “Difficult” Target – Kweder" - Pink Sheet, 28 May, 2007., p. 20).

- M. Nielsen Hobbs (n.hobbs@elsevier.com)

Pediatric Exclusivity Breaks 3-Month Cap In House, But Still Must Find Offset

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