The Food and Drug Practice of Arnall Golden Gregory LLP is pleased to bring you this e-alert with timely updates on the issues currently affecting industries regulated by the U.S. Food and Drug Administration (FDA). We hope you find the information in these recent publications and the upcoming events useful.
AGG Client Alerts
The FTC Sides with Generics on Innovator Sample Drug Availability
In a recent case in the United States District Court for the District of New Jersey, the Federal Trade Commission (FTC) has sided with generic manufacturers regarding access to samples of medicines from innovator drug companies by filing an amicus brief. This filing by the FTC is significant because it is indicative of the careful scrutiny the agency undertakes in its enforcement of the Hatch-Waxman Act and its apparent preferences to protect generic drug market entry. For more information, please click here or contact Jeffrey S. Jacobovitz or Alan G. Minsk.
Despite Growing Momentum Repeal of Medical Device Tax Faces Significant Hurdles
Last week, the Senate approved an amendment that would enable the Senate to repeal the 2.3 percent medical device excise tax that went into effect in January. Despite this approval, it is far from clear that repeal of the tax will occur. For more information, please click here or contact William H. Kitchens.
Sunscreen Industry and Consumers Urge FDA and Congress to Expedite the New Sunscreen Active Ingredient Approval Process
An alliance of skin cancer groups, dermatologists, and sunscreen manufacturers is pushing Congress and the Food and Drug Administration (FDA) to speed up approvals for new sunscreen active ingredients. The alliance, the Public Access to Sunscreens Coalition, is urging Congress and FDA to approve sunscreen active ingredients that have been in use in other countries for at least five years but which have not yet been approved for sale in products in the U.S. For more information, please click here or contact Emalee G. Murphy.
Mobile Medical Applications in 2013: Regulation or Legislation?
On March 4, 2013, the Republican leaders of the House Energy & Commerce Committee, which has jurisdiction over FDA matters, sent a letter to FDA Commissioner Margaret Hamburg with questions about FDA approval of mobile medical applications, including the timeline for such approval and whether any applications have been removed from the market by FDA oversight. The Committee has asked the FDA to respond to the letter by March 15, 2013. For more information, please click here or contact Kim Phan or Emalee G. Murphy.
Selling Your FDA-Regulated Product - 11 Tips for an Effective International Distribution Agreement
If your company is a producer of FDA-regulated products, either in the U.S. or abroad, an international distribution network is a must to access the foreign or U.S. market effectively and efficiently. All distribution agreements present some risks, especially for companies inexperienced in cross-border commercial contracts. This article identifies the top 11 tips to help your company negotiate an effective distribution agreement. For more information, please click here or contact Michael E. Burke.
FDA Enforcement in the Drug Product Promotional Arena: A Year in Review
The year 2012 was an active one for FDA enforcement in the drug product promotional arena. It started with the rollout of FDA’s guidance on responding to off-label requests for information and ended with a “what now” scenario after the United States Court of Appeals for the Second Circuit found unconstitutional the criminal prosecution of a drug company’s sales representative for off-label promotion. And, with 28 enforcement letters sent by FDA’s Office of Prescription Drug Promotion for unlawful promotion, three of which were Warning Letters, the agency enters 2013 with momentum. For more information, please click here or contact Alan G. Minsk.
Alabama Supreme Court Holds Brand-Name Drug Manufacturer Liable for Claims Made by Generic Drug Manufacturer
Alabama’s highest court recently held that a brand-name prescription drug manufacturer may be held liable for injuries caused by competing generics. The decision was heavily influenced by a recent decision of the United States Supreme Court that held that claims against manufacturers of generic drugs for failure to warn are pre-empted by federal law which requires the generic manufacturer’s label to be identical to the brand-name labeling. It remains to be seen whether, in light of the unavailability of a remedy against generic manufacturers, other courts will be willing to impose liability on brand-name manufacturers for harm allegedly caused by products that they did not sell or distribute. For more information, please click here or contact W. Jerad Rissler or William H. Kitchens.
FDA Issues Final Rule on Combination Products cGMPs
On January 22, 2013, FDA issued a final rule on Good Manufacturing Practice (cGMPs) requirements for combination products, such as prefilled syringes and convenience kits. The final rule discusses how manufacturers can demonstrate compliance with cGMPs, including in instances where a combination product has both a device constituent part and a drug constituent part. For more information, please click here or contact Alan G. Minsk.
FDA's Abuse-Deterrent Opioids Guidance Clarifies Intellectual Property Issues, But Leaves Some Questions Unanswered
On January 9, 2013, the U.S. Food and Drug Administration issued its much anticipated draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties. This article discusses the work that FDA will require to secure an "abuse resistant" claim in an opioid product label, and the benefits that should accrue to companies with well-planned intellectual property ("IP") strategies. For more information, please click here or contact Clark G. Sullivan.
Alan Minsk Quoted in Expertbriefings.com Article
Alan G. Minsk was recently quoted in Expertbriefings.com. "It’s very important to check out your dance partner before you go to town with him or her," says Mr. Minsk. "And if you are a pharmaceutical company that is going to enter into a deal with a contract manufacturer, remember this - You need to do your due diligence first! You will want to at least check out that they are FDA compliant, are financially stable and can do the job. You may want to subject them to your own GMP compliance audit before you proceed. Remember that some countries do not have the regulatory oversight of the U.S., so FDA may become suspicious of your business partner...". For more information, please click here or contact Mr. Minsk.
William Kitchens Blogged on PharmExecBlog
On April 4, 2013, AGG Partner William H. Kitchens posted a blog to PharmExecBlog titled "Despite Growing Momentum, Repeal of Medical Device Tax Faces Significant Hurdles." For more information, please click here or contact Mr. Kitchens.
Jeffrey Jacobovitz Quoted in Bloomberg Article
Jeffrey S. Jacobovitz was recently quoted in Bloomberg. The article entitled, "Chinese Vitamin C Makers Fixed Prices, U.S. Jury Says," describes Chinese vitamin C makers who were ordered to pay $162.3 million to U.S. customers for fixing export prices after a federal court jury in New York found their actions weren’t compelled by the nation’s government. The jury of five women and two men in Brooklyn returned a verdict, finding that American dietary supplement firms which filed the antitrust lawsuit proved their case against the Chinese companies. Jurors deliberated for just half a day before reaching a decision to award $54.1 million in damages, which were tripled to $162.3 million under U.S. law. “It was a clear-cut case to them and they didn’t buy that defense at all,” Jeffrey S. Jacobovitz, of Arnall Golden Gregory LLP, said in a phone interview. For more information, please click here or contact Mr. Jacobovitz.
Clark Sullivan and Emalee Murphy to Attend MDMA
AGG Intellectual Property Partner Clark G. Sullivan and Food and Drug Of Counsel Emalee G. Murphy will attend the Medical Device Manufacturers Annual Meeting in Washington, DC , April 15-17. Both Mr. Sullivan and Ms. Murphy work closely with companies in the medical device and IVD industries. For more information, please click here or contact Mr. Sullivan or Ms. Murphy.
Alan Minsk to Speak on the Topic, "Inspection and Preparation for the FDA -- How to Handle Regulatory Audits and Inspections"
On April 23, 2013, Alan G. Minsk will speak at the Global Clinical Supplies Group 2013 Annual Meeting in Santa Ana Pueblo, New Mexico. Conference attendees will have the opportunity to engage with key industry leaders, network with colleagues and participate in a series of workshops of their choosing while having access to over 35 industry specific vendors. For more information, please click here or contact Mr. Minsk.
Hot Topics in Antitrust: What Counsel and Companies Should be Aware Of
On April 25, 2013 from 11:00 am – 12:00 pm, AGG partners Allen I. Hirsch and Jeffrey S. Jacobovitz will be discussing hot topics in antitrust during complimentary Litigation Series webinar presentation. For more information, please click here or contact Mr. Hirsch or Mr. Jacobovitz.
Avoid Warning Letter Disasters With a Strong Contractor Quality Agreement
On May 1, 2013 Alan G. Minsk, will be making his 9th appearance in the highly praised webinar, "Avoid Warning Letter Disasters With a Strong Contractor Quality Agreement." This webinar will help you discover a potential table of contents for your quality agreement and the importance of using FDA defined terms where they exist. Learn the obligations for all stakeholders under a quality agreement, how to develop your quality agreement, and much more. For more information, please click here or contact Mr. Minsk.