Food, Drugs & Device Update – April 2011

Topic of the Month: In Mid-April, the White House unveiled a multi-agency plan aimed at reducing the “epidemic” of prescription drug abuse in the U.S. — including an FDA-backed education program designed to reduce the misuse and misprescribing of opioids. Opioids are synthetic versions of opium that are used to treat moderate and severe pain.

The plan is a collaborative effort involving agencies of the departments of Justice, Health and Human Services, Veterans Affairs, and Defense to provide a national framework for reducing prescription drug abuse and the diversion of prescription drugs for recreational use.

In concert with the White House plan, the FDA announced a new risk evaluation and mitigation strategy (REMS) for all extended-release and long-acting opioid medications. FDA experts noted that extended-release and long-acting opioids are extensively misprescribed, misused, and abused, leading to overdoses, addiction, and even deaths across the United States.

The new REMS plan focuses primarily on: (1) educating doctors about proper pain management, (2) patient selection and other requirements, and (3) improving patient awareness about how to use these drugs safely. As part of the plan, FDA wants companies to give patients education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal.
I. Drug and Biologics Developments
Mail-order self-certification regulations promulgated
Mail-order distributors of scheduled listed chemical products must self-certify to the Drug Enforcement Agency (DEA) that they are following the new regulations established by the Combat Methamphetamine Enhancement Act of 2010 (MEA) so that they may continue to retail them for personal use. The MEA amended the Controlled Substances Act (CSA) to change the regulations for selling scheduled listed chemical products, i.e. nonprescription products that contain ephedrine, pseudoephedrine, and phenylpropanolamine, their salts, optical isomers, and salts of optical isomers.
Under the interim final rule each mail-order distributor must be self-certified at each place of business where they sell these products at retail. For a mail-order distributor, each location that prepares or packages product for distribution to customers, and each location where employees accept payment for these sales, must be self-certified. Mail-order distributors that sell scheduled listed chemical products that are not intended for personal use are not affected by the new regulations. The self-certification will be made on the DEA website and must include a statement that the mail-order distributor understands the requirements under 21 C.F.R. Part 1314 and agrees to comply with the requirements. In addition, mail-order distributors are required to train their employees prior to self-certification. The self-certification requirement became effective April 10, 2011.  DEA Interim Final Rule, ¶40,426

Clinical investigator disqualification procedures proposed

Under a proposed rule, an investigator would be ineligible to conduct any clinical investigation that supported an application for a research or marketing permit for products regulated by FDA if the Commissioner of Food and Drugs determined that the investigator was ineligible to receive test articles such as drugs, devices, or new animal drugs. Generally, disqualification of an investigator is initiated by the appropriate FDA Center depending upon the particular type of test article under study by the investigator in the clinical investigation. The investigator, sponsor, and reviewing institutional review board would be notified about the basis for the disqualification determination. The proposed rule is based in part upon recommendations from the Government Accountability Office and would help ensure adequate protection of research subjects and the quality and integrity of data submitted to the FDA. The agency also would amend the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted. FDA Proposal, ¶46,167


Constituent materials exception regulations implemented

Effective May 13, 2011, the biologics regulations will be amended to permit the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) or the Director of the FDA’s Center for Drug Evaluation and Research (CDER) to approve exceptions or alternatives to the regulation for constituent materials. Constituent materials are ingredients, preservatives, diluents,
adjuvants, extraneous protein, and antibiotics that are contained in a biological product. Current regulations require that all ingredients used in a licensed product, and any diluent provided as an aid in the administration of the product, meet standards of purity and quality.

A request for an exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions of use, including indication and patient population, for which the applicant is seeking approval. The FDA issued the final rule because of advances in developing and manufacturing safe, pure, and potent biological products licensed under the Public Health Service Act that rendered the existing constituent materials regulation too prescriptive and unnecessarily restrictive. FDA Order, ¶40,425

II. Food Developments

Vending machine labeling regulations proposed
Regulations to implement the vending machine labeling provisions of the Patient Protection and Affordable Care Act (PPACA) were proposed by the FDA. PPACA requires that articles of food sold from vending machines permit a purchaser to examine the nutrition facts prior to purchase. The proposed rule provides definitions of key terms including “vending machine operator” and “vending machine.”
The proposed  rule does not provide an exemption from the vending machine nutrition labeling requirements for small businesses, although the FDA maintains that the proposal  provides adequate flexibility to allow small businesses the ability comply with the proposed requirements in a cost-effective and equitable way. Under the proposed rule signs with nutrition information would be placed either in or on the vending machine itself or adjacent to the vending machine and near the food, its price, its selection number, or its selection button. Because the FDA is proposing flexibility for compliance, through the use of signs in, on, or adjacent to vending machines, vending machine operators would be able to choose among a wide variety of less expensive avenues to achieve compliance, depending on their situation.  FDA Proposal, ¶46,165
Nutrition information for standard menu items proposed
Requirements for providing certain nutrition information for standard menu items in chain restaurants and similar retail food establishments would be established under a proposed rule by the FDA. The Patient Protection and Affordable Care Act of 2010 (PPACA), amended the FDC Act to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food; food would be deemed misbranded if the requirements were not met.
Currently, the declaration of nutrition information on the label and labeling of food must include information about the levels of the following nutrients: total calories, calories from fat (unless the product contains less than 0.5 grams of fat), total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamins, and minerals. However, this nutrition information is generally not available for foods sold in restaurants and retail food establishments. According to the agency, providing calorie and other nutrition information in these establishments would assist consumers in making healthier dietary choices. Restaurants and retail food establishments not otherwise covered may elect to become subject to the federal requirements by registering every other year with the FDA.  FDA Proposal, ¶46,166