Food and Drug Newsletter – December 2015

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.

Industry Insights


Breaking News: FDA and Pacira Settle First Amendment Challenge to Off-Label Dispute

By: William H. Kitchens and Alan G. Minsk

On December 14, 2015 a settlement was reached between Pacira Pharmaceuticals, Inc. (“Pacira”) and the Food and Drug Administration regarding Pacira’s First Amendment challenge to FDA’s ability to take enforcement action against the company’s truthful and non-misleading communications about an FDA-approved drug. As we noted in previous Client Alerts, Pacira filed a Complaint in the U.S. District Court for the Southern District of New York on September 8, 2015, challenging FDA’s authority to limit the scope of promotion of Pacira’s approved drug, Exparel® for treatment of pain in only the specific surgical procedures that were studied in clinical trials (bunion and hemorrhoid surgeries). While the drug’s FDA-approved label noted that the drug had not been studied for use with other surgeries, the label did not explicitly state that the medication could only be used for surgeries that had been studied. This lawsuit was filed one month after the same court held that FDA cannot prosecute companies under the Federal Food, Drug, and Cosmetic Act for truthful, non-misleading communications about an approved drug, even if they involve off-label uses. More > 

FDA Stays Final Guidance on INDs for Foods

By: Alan K. Parver and Leah M. Stone

On October 30, 2015, the Food and Drug Administration announced in the Federal Register a stay of certain portions of a September 2013 final guidance for clinical investigators, sponsors and institutional review boards (IRBs) entitled “Investigational New Drug Applications – Determining Whether Human Research Studies Can Be Conducted Without an IND.” The stay is related to portions of the guidance pertaining to foods and was effective on the date of the publication of the notice in the Federal Register. The FDA will accept comments on the guidance at any time. More > 

Off-Label Promotion and Product Liability: Are Industry’s Recent Court Wins in One Space a Win in the Other?

By: Alan G. Minsk

The pharmaceutical industry has recently felt empowered and emboldened by recent litigation that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e., off-label, so long as the information is truthful and not misleading. However, companies must, nevertheless, consider potential product liability ramifications. There is no indication that, because firms may now be allowed certain latitude in one area, they are immune from product liability exposure. More >


Centers for Medicare & Medicaid Services Releases Fee Schedule Amounts for DMEPOS for 2016

By: Alan K. Parver and Leah M. Stone

On November 23, 2015 the Centers for Medicare & Medicaid Services announced the fee schedules for 2016 for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). For items and services not included in product categories covered by the competitive bidding program, there is a fee schedule update factor of -0.4 percent. The negative payment adjustment for 2016 is the result of a 0.1 percent CPI-U increase, which is adjusted downward by a 0.5 percent multi-factor productivity adjustment. In addition, due to new Medicare requirements applicable to items included in the DMEPOS competitive bidding program, the payment rates for these items in 2016 in non-competitive bidding areas will be lower than the 2015 rates. 
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Tell Me, Tell Me, Where I’m Going: Recent FDA Presentation Offers a Crystal Ball Into Medical Device Inspectional Priorities and Compliance Activities

By: William H. Kitchens and Alan G. Minsk

Our law firm recently hosted a program where local Food and Drug Administration district representatives discussed agency inspections of medical device companies. The information presented was a compilation of information from FDA’s website. We thought the presentation was a good summary, as were the agency recommendations to respond to FDA enforcement actions. More > 

Bills Introduced to Modify Payments for DMEPOS

By: Alan K. Parver and Leah M. Stone

Two bills have been introduced in the House of Representatives and the Senate to modify payments for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). On November 19, 2015, Senator John Thune (R-SD) introduced the “DME Access and Stabilization Act of 2015” (S. 2312), and on December 8th Representative Tom Price (R-GA) introduced the “Protecting Access through Competitive-pricing Transition Act of 2015” or the “PACT Act of 2015.” Both bills would modify the method for adjusting payments for DMEPOS in non-competitive bidding areas (non-CBAs) and raise the bidding ceilings for DME subject to the competitive bidding program. However, the bills have significant differences. The Senate bill would cap federal Medicaid reimbursement to states for DME at the level of Medicare payment rates for the same items; the House bill does not include this provision. The House bill would establish licensure and performance guarantee requirements under the competitive bidding program. In addition, it would establish a DMEPOS market-pricing program demonstration project. These provisions are not included in the Senate bill. More >