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
PHARMACEUTICALS
Help! I Need Somebody: FDA to Hold a Public Workshop Concerning the Drug Supply Chain Security Act
By: Alan G. Minsk
Congress, the Food and Drug Administration, the pharmaceutical industry, and the general public are concerned about ensuring the safety and security of the pharmaceutical distribution supply chain. The Drug Supply Chain Security Act (DSCSA) attempts to tackle such concerns. On April 5 and 6, 2016, channeling John Lennon and The Beatles, the Food and Drug Administration will seek help from everybody, by holding a public workshop at the agency’s White Oak Campus in Silver Spring, Maryland, and soliciting comments to review pilot projects. More >
Native Advertising: How Life Sciences Companies Can Manage The Associated Regulatory and Competitive Risks
By: Anuj Desai
Native advertising. Most of us have seen it. Some of us do it. What is it? Quite simply, it is advertising that is perceived and experienced quite like the content around it. For example, native advertising can be a one-page “article” in an outdoor living magazine about a new allergy nasal spray targeted at avid hikers; the ad is typically sandwiched between similar content. The goal is to provide the consumer with an interesting and seamless experience while having an opportunity to promote the advertised goods or services. And native advertising is not just for print – you can find it online, on mobile devices, in your social media feed, in video – pretty much everywhere. More >
King of Pain: FDA Plans to Re-Review Its Opioid Policies
By: Alan G. Minsk
The Food and Drug Administration announced recently that it intends to re-evaluate its policies on opioid medications, designed “at reversing the epidemic, while still providing patients in pain access to effective relief.” The agency said that drug overdose deaths are now the leading cause of injury death in the United States. While FDA is not trying to steal Sting’s title as the King of Pain (see The Police’s 1983 song by the same name), it is trying to demonstrate its plan to play a major role in combatting opioid abuse and misuse. More >
MEDICAL DEVICES
Improving Disclosure for Public Life Science Companies
By: Joseph Alley, Jr. and Robert F. Dow
In recent years, the Life Sciences sector has been one of the hottest sectors for initial public offerings. With the growing market for life science companies has come increased scrutiny of their public disclosure. Companies launching new offerings of securities are subject to intense review by the Securities and Exchange Commission (SEC) staff and, in addition, the SEC staff generally reviews the disclosure documents of all SEC-registered companies at least once every three years. More >
NEWS FROM WASHINGTON
Government Charges Five, Including Two Scientists, With Stealing Trade Secrets And Confidential Information From GlaxoSmithKline
By: Sara M. Lord and Elizabeth A. Mulkey
On January 20, 2016, the United States Attorney’s Office for the Eastern District of Pennsylvania announced the indictment of five people, including two research scientists at GlaxoSmithKline (“GSK”), on charges of stealing trade secrets from the company, wire fraud in connection with the theft of confidential information, money laundering and conspiracy. While the majority of the charges in the 43-count indictment focus on the role of Yu Xue, described in the indictment as “one of the top protein biochemists in the world, the indictment describes an elaborate scheme to sell the stolen information through companies in China, and to launder the proceeds. More >
