FDA Issues Proposed Rules for Antiseptic Drug Products

The U.S. Food and Drug Administration (FDA) issued a new proposed rule to amend its 1994 tentative monograph for OTC antiseptic drug products.  The FDA is proposing to establish new conditions under which OTC consumer antiseptic products are generally recognized as safe and effective ("GRASE").  The FDA states that additional safety and effectiveness data are necessary to support a GRASE ruling for OTC antiseptic active ingredients intended for repeated daily use by consumers.  The Proposed Rule does not affect hand sanitizers, wipes or antibacterial products used in hospitals and other healthcare settings.

According to the FDA, no evidence exists that these products are more effective in preventing illness than washing with regular soap and water.  Further, some antibacterial chemicals used in OTC consumer antiseptic soap products (such as triclosan) may affect certain hormones in the body and contribute to the growing problem of antibiotic resistance.

Based on the data currently available, the FDA finds with this new Proposed Rule that consumer antiseptic wash active ingredients can be considered neither safe nor effective for use in OTC consumer antiseptic wash drug products.  The new rule will be effective one year after it is finalized.  After the effective date, all OTC consumer antiseptic products that do not comply with all requirements in the monograph will be deemed misbranded if they are not subjects of approved New Drug Applications ("NDA").

The FDA is accepting public comment on the Proposed Rule, as well as new data or information, for 180 days.  After the comment period, the FDA will review all available data as well as newly submitted data to determine if the information is adequate in determining the safety and effectiveness of OTC consumer antiseptic active ingredients intended for repeated daily use.

FDA Issued Final Guidance on Mobile Apps

Today the FDA released a final guidance document outlining the agency's approach to mobile apps.  According to the guidance document, the FDA intends to exercise enforcement discretion for the majority of mobile apps that pose minimal risk to consumer (meaning the FDA will not regulate these apps as medical devices).  These include mobile apps that:

• Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
• Provide patients with simple tools to organize and track their health information;
• Provide easy access to information related to patients’ health conditions or treatments; 
• Help patients document, show, or communicate potential medical conditions to health care providers; 
• Automate simple tasks for health care providers; or
• Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems.

Instead, the FDA intends to focus its oversight on mobile medical apps that:

• are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
• ransform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

For more information: Mobile Medical Applications Final Guidance: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

FDA Finalizes Rule and System to Identify Medical Devices

The Food and Drug Administration (FDA) issued a long-awaited rule today requiring companies to include codes on medical devices that will allow tracking and monitoring of the devices. 

The rule consists of two parts: unique device identifiers (or UDI codes) assigned by device makers to their devices, and a public database (called Global Unique Device Identification Database or GUDID) containing the UDI codes that will be managed by the FDA.

The FDA said medical device records will have to include the UDI code.  The rule also establishes accreditation requirements for agencies that may operate systems for issuing UDI codes.

The FDA plans to phase in the UDI rule.  All Class III devices must carry UDI labels within 1 year.  Most Class II devices must comply within 2 years, and any Class I devices not exempt from the rule will have 5 years to comply. 

The new rule is effective 90 days after today's publication in the Federal Register.

• FDA's News Release on the new rule: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369276.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
• Final rule: https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system
• Draft guidance on GUDID: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

Freedom of Information Act Requester Scored Win at Federal Appeals Court

The U.S. Court of Appeals for the D.C. Circuit issued a major ruling last week preserving the rights of Freedom of Information Act (FOIA) requesters to proceed to court quickly when agencies don't comply with the legally required timelines to respond to demands for government records.

The court held that FOIA requires agencies to review responsive documents and to tell requesters what documents the agency will produce, what it will withhold, and why, within 20 days of receiving the request (in some cases, 30 days).  Otherwise the agency risks incurring a challenge in federal district court.

In 2011, a lower court ruled that an agency's acknowledgement of a request was enough to trigger the legal requirement that a requester pursue an administrative appeal with the agency before going to court.  However, the three-judge panel of the U.S. Court of Appeals for the D.C. Circuit unanimously rejected that stance.
 
By allowing requesters to sue when the time limit is up, the D.C. Circuit decision will likely accelerate some responses in some cases and make it more difficult for agencies to selectively delay requests.

FDA Regulates Keyword Searches on the Internet

The U.S. Food and Drug Administration recently sent a Warning Letter to M.D.R. Fitness Corp., a Florida-based researcher and manufacturer of nutritional supplements.  In the letter, the FDA alleges a number of problems, but the one that's catching attention concerns the company's website search engine.

According to the FDA, typing the keyword "cancer" or "diabetes" into the product search field located on the company's website brings up several products.  Because those products are associated with disease terms, the FDA said, the company is thus “implying that its products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases,” which make them unapproved new drugs.

In a previous case, the FDA used metadata as evidence of intended use involving another company's dietary supplement.  Metadata are similar to keyword association in that both are largely invisible to the public.  These recent cases indicate that the FDA is targeting word associations on product websites.