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May 4, 2015

FDA Issues Draft Guidance For Assessment Of Drugs With Potential Estrogenic, Androgenic, Or Thyroid Pathway Activity, and Other Recent FDA Developments

The ACTA Group

FDA Announces GUDID Public Website: On May 4, 2015, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that the data submitted to the Global Unique Device Identification Database (GUDID) are now publicly available. The website, in partnership with the National Library of Medicine, is part of the phase-in for the Unique Device Identification compliance timeline and offers anyone access to search or download information submitted for medical devices. For more details, see

EPA Issues Interim Guidance Concerning Antimicrobial Data Requirements: On April 30, 2015, the U.S. Environmental Protection Agency (EPA) issued interim guidance that clarifies its toxicology data requirements for antimicrobial pesticides used on food contact surfaces. If pesticide residues in food resulting from use on food contact surfaces are 200 parts per billion (ppb) or less, EPA requires certain toxicology data. If residues are greater than 200 ppb, additional data may be required, depending on other conditions such as test results. The interim guidance clarifies that the 200 ppb trigger is based on total estimated daily dietary intake for an individual, and not on the amount of residue present on a single food. According to EPA, its interpretation is consistent with the FDA’s policy. The interim guidance also clarifies EPA’s 2013 amendments to data requirements for antimicrobial pesticides that were designed to make the registration process for these pesticides more efficient and transparent. The interim guidance is intended to fulfill a condition of a March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC), following ACC’s lawsuit challenging the data requirements regulation in the U.S. Court of Appeals in the District of Columbia. Under the settlement agreement, EPA is required to propose by September 2, 2017, certain corrections to 40 C.F.R. § 158.2230(d) to make the rule’s language consistent with the FDA’s use of the 200 ppb. EPA also issued a letter to antimicrobial registrants with information about how the Agency has been implementing Part 158W with respect to existing registered antimicrobial pesticides as well as new and pending antimicrobial pesticide applications. Both the interim guidance and the implementation letter are available online. The settlement agreement and additional documents are available at in docket EPA-HQ-OPP-2008-0110. For more information on antimicrobial policies and guidance, visit online.

FDA Seeks Comments On Risk Assessment For Drug Residues In Milk: On April 30, 2015, Center for Food Safety and Applied Nutrition (CFSAN) announced the availability for comment of a risk assessment entitled “Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products.” 80 Fed. Reg. 24260. This project was in response to a request from the National Conference of Interstate Milk Shipments (NCIMS) and provides a ranking model for four specific criteria to assist in scientific decision support. The model also addresses potential data gaps and research needs. Comments are due by July 29, 2015.

FDA Issues Draft Guidance For Assessment Of Drugs With Potential Estrogenic, Androgenic, Or Thyroid Pathway Activity: FDA announced on April 29, 2015, the release of draft guidance for industry entitled ”Environmental Assessment: Questions and Answers Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity” in accordance with 21 C.F.R. § 10.115. 80 Fed. Reg. 23802. This guidance addresses specific considerations for drugs that have potential estrogenic, androgenic, or thyroid pathway activity (E, A, or T activity) in environmental organisms. The draft guidance document is available online. Sponsors of drugs with potential E, A, or T activity should consult with FDA early in product development to determine whether an environmental assessment will be required for new drug applications (NDA) and certain NDA supplements, or whether a claim of categorical exclusion would be acceptable, and what information should be included in either case. Categorical exclusions for actions related to human drugs and biologics are listed in 21 C.F.R. § 25.31. This guidance focuses on the categorical exclusion for actions on NDAs and NDA supplements that would increase the use of an active moiety, but at an estimated concentration of the substance at the point of entry into the aquatic environment below 1 ppb (21 C.F.R. § 25.31(b)). Once issued in final, this guidance will represent FDA’s current thinking on this topic, but will not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative approaches could be used to satisfy the requirements of applicable statutes and regulations. Electronic or written comments on this draft guidance may be submitted at any time, but comments to be considered during FDA’s review of the draft guidance should be submitted by June 29, 2015.

FDA Issues Letter To Bottled Water Manufacturers: On April 27, 2015 FDA’s CFSAN issued a letter to industry regarding recommendations for fluoride added to bottled water. FDA and the U.S. Public Health Service (PHS) conducted a review of the scientific literature with a panel of scientists and determined the recommended levels to ensure fluoride levels in drinking bottled water are not excessively high, leading to increased risk of discoloration of tooth enamel in children. For more details, see online.

FDA Issues Draft Guidance On Clinical Studies: On April 21, 2015, CDRH issued draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States.” 80 Fed. Reg. 22205. The purpose of the draft guidance is to provide industry insight into FDA’s current policy regarding the use and acceptance of clinical data in support of premarket approval collected from studies conducted outside the U.S. and includes important details that should be considered. To ensure that FDA considers comments on this draft guidance before it begins work on the final version, comments should be submitted by July 20, 2015.

Senators Introduce Bill To Strengthen Personal Care Product Oversight: Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) on April 20, 2015, introduced the Personal Care Products Safety Act (S. 1014) to protect consumers and streamline industry compliance by strengthening FDA’s authority to regulate the ingredients in personal care products. Federal regulations on these products have not been updated in 75 years, according to Feinstein and Collins. The bill would require FDA to evaluate a minimum of five ingredients per year to determine their safety and appropriate use. The review process set forth in the bill would provide companies with clear guidance about whether ingredients should continue to be used and if so, what the concentration levels should be and whether consumer warnings are needed. For example, a chemical may be deemed inappropriate for use in children’s products, or appropriate for professional application only. The first set of chemicals for review includes:

  • Diazolidinyl urea, which is used as a preservative in a wide range of products, including deodorant, shampoo, conditioner, bubble bath, and lotion;
  • Lead acetate, which is used as a color additive in hair dyes;
  • Methylene glycol/formaldehyde, which is used in hair treatments;
  • Propyl paraben, which is used as a preservative in a wide range of products, including shampoo, conditioner, and lotion; and
  • Quaternium-15, which is used as a preservative in a wide range of products, including shampoo, shaving cream, skin creams, and cleansers.

The bill would provide streamlined federal standards so that the personal care products industry knows what to expect and companies can plan for the future with certainty. The Personal Care Products Safety Act would also:

Provide FDA the authority to order recalls of certain personal care products that threaten consumer safety.

Provide FDA the authority to require labeling of products that include ingredients not appropriate for children and those that should be professionally administered. Complete label information, including ingredients and product warnings, would also be required to be posted online since approximately 40 percent of personal care products are purchased over the Internet.

Require companies to provide contact information on their products for consumers and report serious adverse events to FDA within 15 days, including death, hospitalization, and disfigurement. Health effects that could have resulted in hospitalization without early intervention would also be required to be reported.

Require manufacturers to register annually with FDA and provide FDA with information on the ingredients used in their personal care products.

Direct FDA to issue regulations on Good Manufacturing Practices for personal care products.

To fund these new oversight activities, the bill would authorize FDA to collect user fees from personal care products manufacturers similar to what is done for medications and medical devices.

FDA Publishes Guidance On Expedited Access For Premarket Approval: On April 13, 2015, FDA’s CDHR issued guidance entitled “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” 80 Fed. Reg. 19669. FDA intends the guidance to assist companies through a voluntary program for certain devices that are subject to premarket approval and also details how the Expedited Access Pathway (EAP) program will provide patients with access to breakthrough technologies for unmet medical needs. The EAP program became effective April 15, 2015.

FDA Publishes Guidance On Data Collection: On April 13, 2015, CDRH issued guidance entitled “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.” 80 Fed. Reg. 19672. The guidance outlines how FDA considers postmarket controls for reduction of data collection for premarket approval while ensuring access to devices that are safe and effective.