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February 2011
Topic of the Month: The FDA proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices. In addition to detailing the review program, the agency also described the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that the FDA would use to evaluate device submissions and determine their appropriateness for marketing. The agency expects the submissions to generally be approval pathways intended for either high risk or novel products. The FDA could conduct premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications.
I. Agency Developments
Amendment to laxative tentative final monograph proposed
The tentative final monograph for over-the-counter (OTC) laxative drug products, including the individual sodium phosphate salts (dibasic sodium phosphate, monobasic sodium phosphate, and the combination of dibasic sodium phosphate/monobasic sodium phosphate salts in a solution dosage form), used to relieve occasional constipation would be amended by the FDA in a proposed rule as not generally recognized as safe (GRAS) for bowel cleansing. The proposed rule also would withdraw the professional labeling proposed for the individual sodium phosphate salts. Professional labeling is additional information about an OTC drug that is directed to healthcare professionals who prescribe, administer, or dispense medications and is not included in OTC drug product labeling for consumers. The FDA initiated the proposed rule after a careful review of new data and information on the serious side effects associated with the customary dose of OTC sodium phosphates solution (approximately 60 grams (g) of sodium phosphates taken in two 45-milliliter (mL) doses 12 hours apart or approximately 50 g of sodium phosphates taken in a 45-mL dose followed by a 30-mL dose 12 hours later) for bowel cleansing prior to colonoscopy. The proposed rule is also part of the FDA’s ongoing review of OTC drug products and consistent with the agency’s determination that oral sodium phosphate salt products indicated for bowel cleansing should be limited to prescription only. FDA Proposal, ¶46,163
GAO: reassessment of approach to false or misleading food claims
The FDA’s efforts to protect consumers from false or misleading claims are conducted in a challenging environment, according to a report by the Government Accountability Office (GAO). By statute, health claims on food labels must have significant scientific agreement, but in response to a federal appellate court ruling in Pearson v. Shalala (¶38,572) that the First Amendment does not permit the FDA to prohibit a potentially misleading health claim on a dietary supplement label unless the FDA considers whether qualifying language on the label could negate the potentially misleading nature of the claim, the FDA decided to allow qualified health claims with less scientific support.
The GAO examined (1) the results of the FDA's efforts to allow the use of qualified health claims and oversight of these claims and (2) consumers' understanding of the claims. The GAO also examined FDA's oversight of structure and function claims. After it reviewed FDA documents and consumer studies and interviewed stakeholders from health, medical, industry, and consumer groups, the GAO offered three recommendations to ensure that the health-related claims on food labels are not false or misleading to consumers:
From 2002, when FDA announced its decision to allow qualified health claims on food labels, following the Pearson decision, through September 2010, the agency received 16 petitions from companies proposing 60 claims on food labels. After reviewing the scientific evidence presented
in the petitions, the FDA determined that there was enough credible scientific evidence for the agency to allow the use of 12 qualified health claims, by modifying language to qualify the claims and characterize in detail the strengths and limitations of the scientific support for those claims. The FDA has issued only two warning letters to food companies, both in 2010, for citing health benefits that were not in the allowed qualified health claims or supported by scientific
evidence.
Additionally, the GAO noted that consumers found it difficult to understand the differences between health claims with significant scientific agreement and the lower level of scientific support for qualified health claims. Consumers found it difficult to distinguish among the many different types of claims on food labels, including health claims, qualified health claims, and structure and function claims. However, the FDA has not given companies guidance on the scientific support needed to prevent false or misleading information for a structure and function claim for food or given its inspectors instructions for identifying potentially false or misleading information in such claims when examining food labels as part of food facility compliance inspections. According to the GAO, even if the FDA were to provide such guidance, structure and function claims posed a serious oversight dilemma for the agency. Unlike the Federal Trade Commission, which can require companies to submit any relevant evidence as part of an investigation of whether claims are substantiated, the FDA did not have the ability to compel companies to turn over their substantiation documents. GAO Report, 11-102
II. Drug and Biologics Developments
Leukocyte reduction prior to blood storage draft guidance issued
A revised draft guidance titled “Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion” was published by the FDA to provide blood establishments with recommendations for pre-storage leukocyte reduction of whole blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte reduction process. The document incorporates revisions after the FDA’s review of comments on the original draft guidance and replaces the draft guidance of the same title dated January 31, 2001 (66 Federal Register 8410). According to the revised draft guidance, statistical methods for validation and quality control monitoring of the leukocyte reduction process are recommended. The agency will give consideration to the distinction between process and non-process failures. The FDA also recommended that blood establishments reduce component loss by identifying donors whose blood failed to filter successfully and to divert subsequent donations from such donors for uses other than leukocytes reduced transfusable whole blood and blood components. A mixing device during blood collection was recommended, because of incomplete passage of collected blood through leukocyte reduction filters that resulted in wasted blood resources. FDA Notice, ¶42,085
Positron emission tomography drug application guidance issued
Sponsors would not be required to conduct clinical trials or submit new safety and effectiveness information to obtain approval for fludeoxyglucose F 18 injection, ammonia N 13 injection, or sodium fluoride F 18 injection used in positron emission tomography (PET) imaging according to a revised draft guidance published by the FDA. Titled “PET Drug Applications - Content and Format for NDAs and ANDAs,” the draft document recommends that manufacturers of certain PET drugs during the submission of new drug applications (NDAs) or abbreviated new drug applications (ANDAs) need only reference in marketing application
the published literature or the FDA’s determination of safety and effectiveness for these drugs described in the PET Safety and Effectiveness Notice for specific indications. In order to continue marketing these PET drugs for clinical use, manufacturers of these drugs must submit NDAs of the type described in section 505(b)(2) of the FDC Act or ANDAs under 505(j) of the FDC Act by December 12, 2011. Additionally, the draft guidance recommends when submission
of a 505(b)(2) application or ANDA is appropriate and describes the information that manufacturers of these PET drugs should include in each type of application. FDA Notice, ¶42,087