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FDA Proposed Rules Affecting Clinical Research

In December 2006 the FDA released two proposed rules regarding investigational drugs. In one, the FDA proposes expanding what patient populations may access investigational drugs for treatment use. In the second the FDA updates its rules regarding how and when a sponsor may request authorization to charge for investigational or comparator drugs.

Expanded Access to Investigational Drugs for Treatment Use
On December 14, 2006, the FDA published a proposed rule regarding expanded access of investigational drugs for treatment purposes. The current FDA regulations governing clinical research already include a provision authorizing patient access to investigational drugs under a "treatment protocol" or "treatment IND" if certain criteria are met such as treatment of serious or life-threatening diseases or conditions without adequate available therapy. (See 21 CFR § 312.34).

The FDA is proposing the revised rule "to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient" and to "ensure the continued integrity of the scientific process that brings safe and effective drugs to the market."

These changes would expand access to treatment INDs for large population, intermediate-size population, and individual patients. The proposed rule sets forth new criteria that FDA will use to evaluate treatment IND applications but retains an IRB approval requirement.

The FDA is collecting public comments on the proposed rule and a final rule is expected in mid-2007. Read the proposed rule here.

Charging for Investigational Drugs
On December 14, 2006, the FDA published a proposed rule regarding charging for investigational drugs. Under current FDA regulations, sponsors may seek authorization to charge for investigational drugs to recover the costs associated with the manufacture, research, development, and handling of the investigational drug.

The proposed rule revises the criteria FDA will use to evaluate a sponsor’s request. When the sponsor seeks to charge for the unapproved drug under investigation in a study, the proposed rule requires a sponsor to provide evidence that (1) the drug’s potential clinical benefits offer significant advantages over available products, (2) that the study is necessary for development of the drug, and (3) that charging is necessary for the study to be conducted (e.g., the study might not otherwise be conducted because of its high cost).

The proposed rule puts forward less stringent criteria when the sponsor seeks authority to charge for use of approved drugs that are crucial components of an investigational study (e.g., when the approved drug is used as a comparator) or when a noncommercial sponsor (e.g., sponsor-investigator) seeks to charge for an approved drug to study the drug in a clinical trial for a new indication or to obtain important safety information about an approved indication. In cases of making an investigational drug available for treatment use, the proposed rule would permit charging in some cases so that the sponsor can recover its costs.

Finally, the proposed rule clarifies the direct costs for which charging is permissible (e.g., manufacturing costs, shipping costs, storage costs, etc.) and the indirect costs for which charging is impermissible (e.g., costs incurred to produce the drug for commercialization).

The FDA is collecting pubic comments on the proposed rule. A final rule is not expected until mid-2007. Read the proposed rule here.

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