Food and Drug Newsletter - December 2015

by Arnall Golden Gregory LLP

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. 
More > 

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 >

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Arnall Golden Gregory LLP | Attorney Advertising

Written by:

Arnall Golden Gregory LLP

Arnall Golden Gregory LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.