Regulatory Roundup
 
The US Food and Drug Administration will begin requiring device manufacturers to provide information in certain premarket applications regarding “pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use.” The new rule stems from the 2007 FDA Amendments Act. “Very few devices are developed or assessed specifically for use in pediatric patients, those 21 or younger at the time of treatment or diagnosis. This effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations,” according to an FDA press release on the rule, which will also help the agency track approved devices that could benefit pediatric patients. See FDA’s Center for Devices and Radiological Health—Pediatric Medical Devices for more information.

FDA has published two new guidances for industry based on the Step-4 version of the International Conference on Harmonization’s (ICH) Q4B Annexes 7 and 9. The Q4B guideline covers the Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions. Annex 7 addresses dissolution testing and Annex 9 addresses tablet friability. The ICH steering committee adopted the two annexes last October. The FDA guidances allow industry to use the US Pharmacopeia, European Pharmacopeia, and Japanese Pharmacopeia interchangeably for these tests, although FDA can require exceptions at any point. For example, the FDA guidance for Annex 7 does not allow dissolution tests that involve enzymes; delayed-release, gastroresistant, or enteric-coated dosage forms; or large vessels to be interchangeable with the other pharmacopeial requirements. In October 2009, ICH also adopted Annex 10 on polyacrylamide gel electrophoresi, which FDA is expected to publish soon. It is the responsibility of each regulatory ICH member (FDA, EU, and MHLW) to publish approved ICH guidelines for its own region in an effort to harmonize standards.

FDA approved a new formulation for OxyContin that is designed to discourage misuse and abuse of the drug. “Because of its controlled-release properties, each OxyContin tablet contains a large quantity of oxycodone, which allows patients to take their drug less often. However, people intent on abusing the previous formulation have been able to release high levels of oxycodone all at once, which can result in a fatal overdose and contributes to high rates of OxyContin abuse,” according to an FDA press release. “The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication.” Purdue Pharma (Stamford, CT), the manufacturer, will have to conduct a postmarket study on the new formulation and its effect on abuse and misuse. FDA published a list of recently approved Risk Evaluation and Mitigation Strategy (REMS) plans. Manufacturers provide the information in compliance with as part of the 2007 FDA Amendments Act.

Acting at the request of FDA, US Marshals seized several consumer products from Beehive Botanicals (Haywood, WI) last week for misbranding violations of the Federal Food, Drug, and Cosmetic Act. Products included creams, capsules, tablets, gum, throat spray, and shampoos. The company’s website made claims about the products' ability to diagnose, cure, and prevent diseases such as asthma, dermatitis, and ulcers, or about the products' antibiotic or antiviral properties, according to a Mar. 3, 2010 FDA press release. FDA issued a Warning Letter to the manufacturer in March 2007 regarding its marketing and promotional materials.