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  July 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.

In this Issue

 Industry Insights



GAO Recommends Congress Reduce Incentives for Prescribing 340B Drugs
By: Neil W. Hoffman and Maxwell P. Clayton

The United States Government Accountability Office (GAO) recently released a report entitled “Medicare Part B Drugs: Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals” (“the “Report”). The 340B Drug Pricing Program requires Medicare participating drug manufacturers to sell certain outpatient drugs at discounted prices to qualifying health care providers, including the 40 percent of all U.S hospitals that serve a disproportionate share of low-income patients or fall under other specified criteria. Medicare reimburses these hospitals (“340B Hospitals”) for the drugs using a statutorily defined formula that is unaffected by their actual purchase price, which GAO indicated could incentivize overprescribing of 340B drugs to “maximize the revenue generated by the difference between the actual cost of the drugs and their reimbursement.” The GAO was particularly concerned with those 340B Hospitals that serve a disproportionate number of low-income patients (“340B DSH Hospitals”), as they account for 80 percent of all 340B drug purchases. More >

The OIG Applauds FDA’s Progress in Inspections of Generic Drug Manufacturers but Recommends More to be Done
By: Alan G. Minsk and Alexander B. Foster

The Department of Health and Human Services’ Office of Inspector General has recently recommended that the Food and Drug Administration continue to increase its pre-approval inspections of generic drug companies. The OIG noted that, in 2012, nearly 80% of prescriptions filled in the U.S. were for generic drugs. This article contains some highlights of the OIG report. More >



Georgia Senator Introduces The Combination Product Regulatory Fairness Act of 2015
By: William H. Kitchens

On July 17, 2015, Georgia’s U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a Senate bill entitled, “The Combination Product Regulatory Fairness Act of 2015.” The bill is intended to streamline device / drug combination approvals at the Food and Drug Administration (FDA) by implementing several new procedures, including letting the agency rely on previously approved premarket approval applications (PMAs) and new drug applications (NDAs) to help support new combination product approvals.
 More >



Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act
By: Alan K. Parver and Leah Mendelsohn Stone

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new treatments and therapies. Over the next several weeks, Arnall Golden Gregory will publish a series of articles analyzing provisions in the 21st Century Cures Act that address: (1) funding for the National Institutes of Health (NIH); (2) new drug development; (3) new device development; (4) interoperability; and (5) Medicare and Medicaid coverage and payment issues. More >


This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and Public Policy Practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information about the Food and Drug Practice, please contact Alan Minsk.
©2015. Arnall Golden Gregory LLP. All Rights Reserved.  Atlanta | Washington, DC

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