Food Drug & Devices – April 2010


I. Drug and Biologics Developments


Electronic prescriptions of controlled substances to address errors

Effective June 1, 2010, practitioners will be permitted the option of writing prescriptions for controlled substances electronically under a Drug Enforcement Administration (DEA) interim final rule amending regulations implemented by the Controlled Substances Act. The DEA revised the regulations to address concerns with prescription errors caused by illegible handwriting and misunderstood oral prescriptions. The regulations permit pharmacies, hospitals, and practitioners with the ability to use modern technology to receive, dispense, and archive electronic prescriptions for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing. The DEA originally published an electronic prescription proposal in 2008 (¶46,129).

In response to commenters’ concerns about the proposal, the DEA adopted a revised approach to identity proofing (verifying that the user is who he claims to be) and logical access control (verifying that the authenticated user has the authority to perform the requested operation). According to the DEA, no single individual will have the ability to grant access to an electronic prescription application or pharmacy application. For individual practitioners in private practice identity proofing will be done by an authorized third party that will, after verifying the identity, issue the authentication credential to a registrant.

In addition, the DEA required registrants to apply with federally approved credential service providers (CSPs) or certification authorities (CAs) to obtain their authentication credentials or digital certificates. Once a CSP or CA has verified the identity of the practitioner, it will issue the authentication credentials necessary to sign electronic controlled substance prescriptions. Possession of the credential will not be sufficient to gain access to the signing function. The final rule allowed for, but did not require, institutional practitioners to conduct identity proofing in-house as part of their credentialing process. DEA Interim Final Rule, ¶40,400.

Changes in prescription drug direct-to-consumer advertising proposed

Major statements relating to side effects and contraindications of advertised prescription drugs in direct-to-consumer (DTC) marketing would be presented in a clear, conspicuous, and neutral manner in a proposed rule by the FDA. The agency’s current prescription drug advertising regulations require a statement on the major side effects and contraindications of the advertised product when used in print and broadcast advertisements. The proposed rule would require television and radio advertisements for human prescription drugs to be clear, conspicuous and neutral, regardless of the manner in which effectiveness information was presented in the advertisement. “Clear and conspicuous” disclosures in ads are:

(1) presented in language that is readily understandable by consumers;

(2) understandable in terms of the volume, articulation, and pacing used in the audio portion;

(3) placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the textual information to be read easily; and

(4) not using distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.

According to the FDA, the disclosure should be presented in language the intended audience would understand, by using lay-terms instead of complex medical phrases.  If a drug’s prescribing information indicates that more than half of patients taking the drug experienced a particular adverse event, the major statement should accurately convey the frequency of this risk such as “more than half” rather than vaguely indicating that “some patients experienced” the particular adverse event.

The FDA was not aware of any existing standards for “neutral” disclosures, and defined it as unbiased, and is providing an opportunity for public comment on the results of empirical studies on how to best provide consumers with risk/benefit information in DTC advertisements. The FDA is also proposing minor changes to update 21 CFR §202.1(e)(1) to make the regulation clearer with punctuation and language substitutions. Submit written or electronic comments by June 28, 2010. FDA Proposal, ¶46,153.

Unilateral patent delisting circumvents congressional intent

A generic drug manufacturer was allowed a 180-day marketing exclusivity period because the FDC Act did not permit a patent holder to unilaterally deprive a first abbreviated new drug application (ANDA) filer of the exclusivity by delisting a patent. According to the U.S. District Court for the District of Columbia on remand, the structure of the FDC Act indicates a clear pro-consumer congressional intent to reward a first ANDA applicant that challenges a brand name manufacturer’s patent with short-term marketing exclusivity. Instead of suing for patent infringement after the generic drug manufacturer filed its ANDA, the brand name manufacturer delisted the patent with the FDA. The agency determined that the generic manufacturer had forfeited its right to exclusivity for failing to go to market within the time period required after delisting, although it had not approved the ANDA nor publicized the delisting. The FDA reversed its position after an appellate court held that the FDC Act did not permit such unilateral action. Under remand, the district court noted the FDA did not act arbitrarily when it issued a determination counter to its original, “clear” interpretation of statutory language. The motion for injunctive relief filed by two competitor generic drug manufacturers was denied.  Apotex v. Sebelius, D. D.C., ¶39,134.




Prescription drug tracking guidance sets standards

A guidance addressing the development of standards and systems for identification, authentication, and tracking and tracing of prescription drugs was published by the FDA. Titled “Standards for Securing the Drug Supply Chain-Standardized Numerical Identification for Prescription Drug Packages,” the guidance was issued pursuant to the Food and Drug Administration Amendments Act of 2007 requirements that the agency develop standards to fight counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs. Standardized numerical identifiers (SNI) must be applied to a prescription drug at the point of manufacturing and repackaging at the package or pallet level, so that drugs can be tracked and traced. The FDA considers the package to be the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended by that manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser of the drug product. The guidance revises a January 2009, draft guidance (¶41,888) of the same title. The guidance does not address how to link a repackager SNI to a manufacturer SNI, nor does it address standards for prescription drug SNI at levels other than the package-level, including case and pallet levels. Standards for track and trace, authentication, and validation are also not addressed in this guidance. FDA Notice, ¶42,009

II. Food Developments


Shell eggs contamination prevention, amended dates of compliance

A Small Entity Compliance Guide (SECG) was issued by the FDA to accompany a July 2009 regulation (¶40,380) that required egg producers with at least 3,000 or more laying hens to institute a number of measures during the production of shell eggs in poultry houses and subsequent refrigeration during storage and transportation to prevent food borne illness caused by the bacterium Salmonella enteritidis. The SECG, “Prevention of Salmonella enteritidis in Shell Eggs During Production, Storage, and Transportation – Small Entity Compliance Guide,” will assist small businesses in understanding regulations that seek to prevent the 79,000 cases of food borne illness caused by the consumption of eggs contaminated with Salmonella. The FDA determined that the economic implications of the rule will be substantial on a number of small entities, and the SECG will provide those entities with plain language explanations. The FDA also amended dates of compliance with the regulations, specifically that farms with 50,000 or more layers must comply by July 9, 2010 and farms with at least 3,000 but less than 50,000 layers comply by July 9, 2012 (75 Federal Register 18751). Farms with less than 3,000 laying hens are exempt. FDA Notice, ¶42,017