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

• Filing Review is About More Than Checking the Boxes; or Is It? 
• Court Dismisses FTC Antitrust Lawsuit Alleging That Shire ViroPharma Inc. Abused Government Processes to Delay Generic Competitors 
• FDA Delays Enforcement of the Postmarketing Safety Reporting (PMSR) Final Rule for Combination Product Applicants 
• FDA Announces “Unique” Restriction on Approved Medical Device
• (Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k)

 Industry Insights

PHARMACEUTICALS

Filing Review is About More Than Checking the Boxes; or Is It?
By: Deborah L. Livornese 

Things sometimes change fast. Our original article described one company’s recent announcement that the Food and Drug Administration refused to file its new drug application as a reminder that the agency’s filing review may be more than a check-the-box exercise to see if the sponsor has submitted something for each required category of information. But, then, earlier this week, the company announced FDA had taken the very unusual step of rescinding that decision and agreeing to review the application without the submission of additional data. More > 

Court Dismisses FTC Antitrust Lawsuit Alleging That Shire ViroPharma Inc. Abused Government Processes to Delay Generic Competitors
By: Jeffrey S. Jacobovitz and Bradford J. Kelley

The Federal Trade Commission (“FTC”) has brought a series of cases recently involving drug manufacturers allegedly seeking to delay competition from generic drug companies. See e.g. FTC v. Activis, Inc., 133 S.Ct. 2223 (2013) (Actavis allegedly entered into reverse payment settlements to delay the entry of generic drug competition). The case described below involving Shire ViroPharma Inc. is another recent example of the FTC’s actions in this field. More >

DEVICES

FDA Delays Enforcement of the Postmarketing Safety Reporting (PMSR) Final Rule for Combination Product Applicants
By: Deborah L. Livornese and Genevieve M. Razick

The Food and Drug Administration issued a final rule setting forth postmarketing safety reporting (PMSR) requirements for combination products subject to premarket review by FDA on December 20, 2016. For some of these requirements, FDA set a January 19, 2017 effective date as it was FDA’s expectation that applicants already be in compliance with these PMSR requirements as they generally refer to existing regulations. A later compliance date of July 19, 2018 was set for certain other PMSR reporting requirements. More > 

FDA Announces “Unique” Restriction on Approved Medical Device
By: Elizabeth A. Mulkey

On April 9, 2018, the Food and Drug Administration announced an additional “unique type of restriction” on the sale and distribution of an approved medical device. FDA issued an order requiring healthcare providers and facilities that offer the Essure permanent contraception device to provide specific information to patients about the risks and benefits of the device. This was not the first step FDA has taken to bolster the presentation of risk information about this device, but the action signifies FDA’s willingness to utilize new methods to oversee how regulated entities promote and distribute medical products. More >

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) 
By: Alan G. Minsk and Elizabeth A. Mulkey

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff.” While not legally binding, the draft provides the agency’s current thinking on how companies may use the Abbreviated 510(k) regulatory pathway to obtain marketing authorization for certain types of medical devices in a more time-effective manner. One notable point is that the new option may allow a company to submit an Abbreviated 510(k) and not have to rely on whether a direct comparison to a predicate device must be shown to demonstrate substantial equivalence. The pathway is intended to “allow more flexibility to use more modern criteria as the reference standard and permit comparisons to standards that more closely approximate the kind of current technology,” according to FDA Commissioner Scott Gottlieb. More >