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

• You're Always a Day Away: DSCSA Product Identifier Requirements Delayed
• House Bill Would Narrow Orphan Drug Exception
• FDA Adds Additional Premarket Notification 510(k) Submission Requirements for Certain Reusable Medical Devices
• NY AG Fines Healthcare Firm $130,000 for Improperly Delaying Breach Notices to Consumers Due to an FBI Investigation

 Industry Insights

PHARMACEUTICALS

You're Always a Day Away: DSCSA Product Identifier Requirements Delayed
By: Deborah L. Livornese and Alexander B. Foster

In recently issued draft guidance related to the implementation of product identifiers under the Drug Supply Chain Security Act ("DSCSA"), FDA has stated that it intends to exercise enforcement discretion for a period of one year beyond the dates delineated in the DSCSA. The decision was made in large part because of industry indications that the initial start dates would not be feasible due to the limited number of expert vendors and the lack of readiness on the part of contract facilities that perform manufacturing operations on behalf of manufacturers. More >

House Bill Would Narrow Orphan Drug Exception
By: Neil W. Hoffman and Alexander B. Foster

A recently proposed House bill entitled The Closing Loopholes for Orphan Drugs Act would narrow the exception for orphan drugs under the federal 340B Drug Pricing Program. Representative Peter Welch (D-VT) introduced the bill on June 13, 2017 in order to "close a loophole” that permits drug companies to deny discounts to certain covered entities for all use of orphan drugs. More >

DEVICES

FDA Adds New Premarket Notification 510(k) Submission Requirements for Certain Reusable Medical Devices
By: Deborah L. Livornese and Genevieve M. Razick

The 21st Century Cures Act included a provision requiring the Food and Drug Administration (FDA) to publish a notice in the Federal Register identifying a list of reusable devices that will be required to include validated instructions for use (IFU) and validation data regarding cleaning, disinfection, and sterilization as part of the premarket notification 510(k) submission. FDA published this notice on June 9, 2017. More >

NEWS FROM WASHINGTON

NY AG Fines Healthcare Firm $130,000 for Improperly Delaying Breach Notices to Consumers Due to an FBI Investigation
By: Kevin Coy

On June 15th, New York Attorney General Eric Schneiderman announced a settlement with CoPilot Provider Support Services Inc. to resolve allegations that the company improperly delayed notice to more than 220,000 consumers of a breach involving their health information by more than a year, including over 25,000 New York residents. The company agreed to pay $130,000 and reform its breach notification practices to settle the matter. More >