Compliance Regulations and Guidance Affecting your Industry

The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.

This guidance is intended to assist applicants in deciding:

(1) what studies should be included in the CLINICAL STUDIES section of prescription drug labeling,

(2) how to describe individual studies, and

(3) how to present study data, including presentation of data in graphs and tables.

The FDA-prescribed adverse reactions section makes it easier for healthcare practitioners to identify adverse reactions that are most important for prescribing decisions.

This guidance document describes the new Medical Device Reporting requirements for manufacturers. It is intended for both domestic and foreign medical device manufacturers, and is based on the Medical Device Reporting (MDR) requirement published in the final rule dated December 11, 1995. The MDR regulation provides a mechanism for FDA to identify and monitor significant adverse events involving medical devices, so that problems may be detected and corrected in a timely manner.

The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects. Institutional Review Board (IRB) reviews and approves the clinical protocol, informed consent forms, study advertisements, and patient brochures.

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

In June 2011, the Food and Drug Administration issued draft guidance on using human factors and usability engineering to optimize medical device design. The aim of this guidance document is to help the medical device industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.

In October 2011, the FDA issued final guidance on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drugs and Biological Products. The aim of the guidance is to help ensure that labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

The Food Safety Modernization Act (FSMA) of 2011 not only formulated regulations to protect consumers by ensuring safety in the manufacture and production of food, but also includes statutes to protect employees who turn whistleblowers.

FDA has developed this draft guidance document to provide greater clarity for FDA reviewers and industry regarding the factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices. FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.

In October 2009 the Federal Trade Commission (FTC) released its final Guides Concerning the Use of Endorsements and Testimonials in Advertising. The Guides revise the FTC's initial guidelines published in 1980, providing advertisers and spokespeople with insight on how to keep their endorsement and testimonial advertisements in compliance with the FTC Act, particularly in light of new issues posed by the emergence of social media. The Guides took effect on December 1, 2009.
 

This document is intended to clarify for FDA personnel and the regulated industry how the agency intends to prioritize its enforcement efforts regarding the pedigree requirements in 21 U.S.C. 353(e)(1)(A) and 21 CFR Part 203 during the first year after the effective date of 21 CFR §§ 203.3(u) and 203.50.

The Prescription Drug Marketing Act aimed at amending the Federal Food, Drug, and Cosmetic Act to ban the reimportation of drugs produced in the United States, to place restrictions on the distribution of drug samples, to ban certain resales of drugs by hospitals and other health care entities, and for other purposes.

An ePedigree or electronic pedigree is an electronic document that satisfies pedigree requirements of prescription drugs. While the FDA hasn’t implemented ePedigree specific regulations for the in the pharmaceutical supply chain, California has formulated laws regarding the use of ePedigrees.

This document address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. It also addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site,2 rather than having to request this information from the Agency and wait for the Agency to respond, as has been the case in the past. The FDA believes that making this information available on the Internet will streamline the guidance process, making it more efficient than the previous process. This process also will provide a meaningful opportunity for the public to consider and comment on BE study recommendations for specific drug products.

This guidance is intended to address two topics pertaining to Medication Guides for drug and biological products. This guidance applies when FDA intends to exercise enforcement discretion regarding when a Medication Guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient4 instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient. The guidance also clarified when a Medication Guide will be required as part of a risk evaluation and mitigation strategy (REMS).