Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

In this Issue

• Pharmaceutical Industry-Sponsored Meals and Prescribing Rates: New Research Shows Link
• FDA’s New Guidance on Data Integrity and Compliance with GMPs and Potential Product Liability Considerations
• FDA Releases Draft Guidances on Compounded Drugs, Helps to Answer “When are they Copies?”
• Update on Medicare Part B Drug Pricing Model
• Industry Activities and Recognition
• Upcoming Events

PHARMACEUTICALS

Pharmaceutical Industry-Sponsored Meals and Prescribing Rates: New Research Shows Link
By: H, Carol Saul and Elizabeth A. Mulkey

A new report published in the Journal of the American Medical Association (JAMA) has noted a link between pharmaceutical industry payments to physicians and prescribing rates for brand-name medication. Specifically, the study found that receipt of industry-sponsored meals affected physicians’ prescriptions of brand-name products relative to generic alternatives in the same drug class. The study compared physician data sets from the Open Payments program and Medicare Part D, evaluating whether there was an association between industry payments and prescribing rates for the brand-name medications that were being promoted. The data focuses on the most-prescribed brand-name drug in each of Medicare Part D’s four drug categories in 2013. Notably, the study points out that there is “limited, mixed, or contrary evidence about the superiority” of these drugs over their generic alternatives. More >

FDA’s New Guidance on Data Integrity and Compliance with GMPs and Potential Product Liability Considerations
By: Alan G. Minsk

The Food and Drug Administration recently released draft guidance for the industry entitled “Data Integrity and Compliance with CGMP [Current Good Manufacturing Practices].” While the draft is not legally binding on industry or the agency, it offers FDA’s current thinking on how drug and biologic manufacturers can comply with current Good Manufacturing Practices in order to ensure completeness, consistency, and accuracy of data. In recent years, FDA has taken numerous enforcement actions against companies for data integrity-related violations during GMP inspections. In addition to describing the agency’s expectations, the document also offers companies a means to reduce potential product liability exposure. More >

FDA Releases Draft Guidances on Compounded Drugs, Helps to Answer “When are they Copies?”
By: Alan G. Minsk and Alexander B. Foster

Some of us remember the television commercial and poster, created by the then-audio cassette company, Memorex, asking “is it live, or is it Memorex?” Forty years later, the Food and Drug Administration could paraphrase the slogan to ask, “Is a compounded drug product essentially a copy of an approved drug product?” FDA recently released two draft guidance documents for industry, entitled “Compounded Drug Products that are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” and “Compounded Drug Products that are Essentially Copies of a Commercially Available Drug Product Under Section 503B of the Federal Food, Drug, and Cosmetic Act [(FDCA)].” While the drafts are not legally binding on industry or the agency, they offer FDA’s current thinking on the ever-evolving issue of pharmacy compounding. Industry has 90 days to submit comments to FDA on the two documents. More >

NEWS FROM WASHINGTON

AGG Attorney Jerad Rissler Selected as Vice Chair of American Health Lawyers Association Group

W. Jerad Rissler has been selected to serve as Vice Chair of Strategic Planning and Special Projects for the American Health Lawyers Association’s (AHLA) Alternative Dispute Resolution Affinity Group (ADR AG).The purpose of the ADR AG is to provide a forum to network and educate members regarding legal developments and best practices in addressing conflicts within the healthcare system. 

AGG Ranks in Top 5 in Hospitals and Health Systems, According to AHLA Survey

AGG was ranked #5 in the US in the area of hospitals and health systems, according to a survey by the American Health Lawyers Association (AHLA). The ranking is based on the number of firm lawyers who participate in the association, which is the country's leading organization for healthcare lawyers.

AGG Partner Alan Minsk will participate on two panels at the RAPS Annual Meeting in San Jose, California on September 19-20, 2016. On one panel, he will discuss recent court developments relating to off-label promotion by pharmaceutical and medical device companies; for the second panel, he will discuss potential individual liability issues that senior management must consider if involved in non-compliance.

AGG Partner Alan Minsk will speak at the Prescription Drug Marketing Act (PDMA) Alliance Annual Conference on September 21, 2016, in Chantilly, VA. Mr. Minsk’s presentation will focus on compliance with speaker agreements.

AGG Partner Alan Minsk will co-present at the 28th FDA Boot Camp in Boston, Massachusetts on September 22, 2016, regarding the basics of FDA’s drug and biologic labeling and promotional requirements.