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
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The Food and Drug Administration recently released draft guidance for the industry entitled “Data Integrity and Compliance with CGMP [Current Good Manufacturing Practices].”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
Update on Medicare Part B Drug Pricing Model
By: Alan K. Parver
On March 11, 2016 the Centers for Medicare and Medicaid Services issued a proposed rule to establish a nationwide demonstration regarding payment for outpatient drugs covered under Medicare Part B. This proposal was reported and summarized in our March 30, 2016 bulletin. Since the issuance of the proposed rule, there have been a number of important developments that we explain. More >
