Pediatric Research Equity Act of 2003

PEDIATRIC RESEARCH EQUITY ACT OF 2003

PEDIATRICS RESEARCH AUTHORITY

    Mr. GREGG. Mr. President, I rise to speak to a managers' amendment to S. 650, the Pediatric Research Equity Act. This amendment makes improvements to the legislation as reported out of the Committee on Health, Education, Labor and Pensions in June. Because these improvements were made after the committee report was filed, this statement is intended to serve as the committee's views on the amended legislation. This statement was shared with the other committee members and has their concurrence.

    Mr. KENNEDY. Mr. President, the Democratic sponsors of the bill and I concur with this statement.

    Mr. GREGG. Mr. President, the purpose of this legislation is to provide FDA with statutory authority to require pediatric studies in specified circumstances. In October 2002, a Federal district court held that existing law did not provide FDA the authority to issue a regulation requiring pediatric studies for drugs marketed to adults but important to children. Although this decision is being appealed, this legislation will provide the agency with definitive statutory authority to require pediatric studies of new and already marketed drugs and biologics in the circumstances specified in the legislation and to enforce any violations of those requirements in Federal court. This has always been the intent of S. 650. After the legislation was marked up in committee, the managers of the bill agreed to amend the language in section 505B(d) to make this intent even clearer.

    The enforcement mechanism in section 505B(d) provides that if a person fails to submit an assessment described in subsection (a)(2) or a request for approval of a pediatric formulation described in subsection (a) or (b) under the new law, "the drug or biological product that is the subject of the assessment or request may be considered misbranded solely because of such failure." This language confers on the Secretary authority to bring a misbranding action where a violation has occurred.

    The committee has used the language "may be considered" (misbranded) rather than the traditional "shall be deemed to be" (misbranded) that is used in other provisions of the Federal Food, Drug and Cosmetic Act in order to emphasized that the Secretary may exercise traditional enforcement discretion in deciding whether to bring such an action. The Committee recognizes that the Secretary retains that discretion under other provisions of current law that use the "shall" formulation. Nevertheless, the Committee intends for this authority to be interpreted by the courts and to be implemented by FDA in a manner consistent with the agency's enforcement authorities in current law that use the "shall" formulation.

    As is true with other provisions of current law, once the Secretary decides to initiate an enforcement action under section 505B(d), no formal finding or other proceeding is required. Moreover, it is not necessary for the Secretary to identify any other misbranding authority in the act. The new authority conferred by section 505B(d) is sufficient. For example, the failure of a sponsor to submit pediatric studies in accordance with the requirements of the legislation alone would be a sufficient basis to prosecute an action in federal district court.

    The managers of the bill have agreed to the extraordinary retroactive application of the provisions of the new research authority in order to avoid even greater potential harm to children through the loss of research and agency resources should assessments, waivers, and deferrals under the Pediatric Rule be considered invalid following the recent district court decision invalidating the rule. This application should not be considered approval of the agency's interpretation of its authority nor disagreement of the court's ruling. In the extraordinary situation at hand, the managers' amendment modifies the effective date provision of the legislation to ensure a seamless transition of the pediatric study requirement from the Pediatric rule to this legislation. The intent is that waivers and deferrals of the study requirement previously granted under the rule be deemed to be in effect under the legislation. A sponsor that received a deferral under the rule would have the original deferral date extended by the number of days between October 17, 2002, and the date of enactment of this legislation.

    A sponsor that submitted an application in the time period between April 1, 1999, and the date of enactment of this legislation that was not granted a waiver or deferral under the rule would be required to submit pediatric assessments unless granted a waiver by FDA. However, no submission by a sponsor would be due until 12 months after the date of enactment of this legislation or until a date specified by FDA under section 505B(a)(3), whichever is later.

    Mr. KENNEDY. Mr. President, Although I and the Democratic sponsors of the bill disagree with the chairman's view that the agency lacked the authority to promulgate the Pediatric Rule and his view that the Federal district court ruling invalidating the rule was correct, we do agree with the chairman's statements regarding the need to apply the requirements of this legislation retroactively to ensure that no pediatric studies are lost in the transition from the rule to this legislation.

    Mr. GREGG. Mr. President, S. 650 provides FDA the statutory authority to require that new and already marketed drugs and biological products be studied in children in specified circumstances. This authority is intended to work in a complementary fashion with pediatric exclusivity. With regard to already marketed products, S. 650 provides that FDA require pediatric testing only after pediatric exclusivity and the National Institutes of Health grant and contract provisions contained in sections 409I and 499 of the Public Health service Act have failed to produce the necessary studies. However, nothing in S. 650 requires FDA to wait until the voluntary mechanisms have failed or been exhausted before invoking the pediatric studies requirement for new drug applications under section 505 of the Federal Food, drug and Cosmetic Act or biological license applications under section 351 of the Public Health service Act. On the contrary, S. 650 creates the presumption that new drugs and biologics will be studied before approval unless a waiver or deferral is granted.

    Mr. KENNEDY. Mr. President, I agree with the Senator. Does he agree as well, that, in accordance with the plain language of the legislation, FDA shall grant a waiver of the requirement to submit pediatric assessments only if the applicant certifies and the Secretary finds that the conditions specified in 505B(a)(4) and 505B(b)(2) exist? By using the word "including" before listing the circumstances under which FDA shall grant a full or partial waiver in the committee report for S. 650, the committee does not intend that any conditions or circumstances other than those specifically stated in 505B(a)(4) and 505B(b)(2) serve as the basis for FDA granting a full or partial waiver of the requirements of the legislation.

    Mr. GREGG. Mr. President, I do, and I thank the Senator for his work on this bill and the report.