Mark Mansour, Partner, Bryan Cave, LLP

FDA Seeks Comments on Proposed Information Collections

The FDA has announced an opportunity for public comment on several proposed collections of information. The agency is seeking comment on information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking. The agency is also seeking comments on a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency also seeks comments on its Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine. Comments are due by April 19, 2010.

In addition, the agency is seeking comments on Antimicrobial Animal Drug Distribution Reports and on its Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff: Humanitarian Device Exemption Regulation: Questions and Answers. Comments are due by March 22, 2010.

FDA Seeks Comments on Proposed Data Falsification Rule

The FDA is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. Comments on the proposed rule are due by May 20, 2010. More information is available here.

Court of Appeals Agrees to Delay E-Cigarette Decision

A federal court of appeals has agreed to stay the decision of the U.S. District Court for the District of Columbia that lifted FDA restrictions on e-cigarettes. The court ruled last month that the FDA misused its authority when it classified e-cigarettes as a drug-device combination and placed the products under an import alert.

Drug Companies May Have to Wait Longer for REMS Final Guidance

It is being reported that the final guidance on risk evaluation and mitigation strategies (REMS) may be delayed, as the CDER staff developing the recommendations must also review all proposed REMS from drugmakers.

Companies Comment on Proposed Combination Products Rule

Manufacturers of combination products, including Johnson & Johnson, have submitted comments on the FDA’s proposed rule on good manufacturing practices (GMPs) for combination products, saying that the rule needs more guidance and should better address legacy products.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

CDRH Publishes Strategic Priorities for 2010

CDRH has published its 2010 Strategic Priorities. The four major identified priorities of CDRH include: fully implementing a total product life cycle approach, enhancing communication and transparency, strengthening the workforce and workplace, and facilitating innovation and addressing unmet public health needs. Within these priorities, CDRH has set forth a timeline, in which it states that it intends to begin implementation of the recommendations of the 510(k) Working Group by September 30, 2010. Director Jeffrey Shuren has indicated that he plans to review public comments from a meeting this month and the findings of an internal review, to be completed this summer, before making any proposals. In its notice announcing this month’s meeting on the 510(k) process, the FDA stated that it is seeking comments pertaining to four areas: predicate devices; new technologies and scientific evidence; practices for managing the high volume of 510(k) submissions; and post-market surveillance.

CDRH has also announced that it intends to launch a “Unique Device Identification” (UDI) system by Sept. 30, 2013.

FDA Moves Radiological Devices Branch to OIVD

FDA Commissioner Margaret Hamburg has signed orders to officially move the Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety, a result of long-term discrepancies between how in vitro and in vivo diagnostics have been regulated by FDA. OIVD will now house four product divisions – the division of chemistry and toxicology devices; immunology and hematology devices; microbiology devices; and radiological devices.

FDA Enforcement Letters on Marketing Campaigns Doubled in 2009

An FDA official has stated that the agency sent 41 enforcement letters in 2009 related to questionable drug-marketing campaigns, almost twice as many as it issued in 2008.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

Trade Groups Urge FDA to Extend Compliance Period for eMDR Rule

The Advanced Medical Technology Association and other trade groups have called on the FDA to extend from one year to two years the period for complying with a proposed rule that would require device firms to electronically file adverse event reports with the agency.

DOJ Prosecutors Turn Attention to Manufacturing, Safety Issues

Recent cases suggest that the Department of Justice is increasingly pursuing cases related to device manufacturing, adverse event reporting and even product labeling. While the Food, Drug & Cosmetic Act does not have whistleblower provisions, Eugene Thirolf, director of DOJ’s Office of Consumer Litigation, has stated that he predicts that future qui tam cases will cite FDC Act violations, such as manufacturing controls or adverse event reporting issues, as evidence of fraud against the government in False Claims cases.

House Bill Would Let FDA Debar Device Researchers

The Strengthening of FDA Integrity Act, H.R. 3932, introduced by Rep. Joe Barton (R-TX), would grant the FDA authority to debar device clinical trial researchers convicted of felonies. The bill also would require the FDA to send annual debarment reports to Congress and would reduce the time it has to debar a researcher from five years to one.

Submitters Still Confused on Adverse Event Reporting to ClinicalTrials.gov

Device and drug firms that submit details about their clinical trials to ClinicalTrials.gov are still having problems reporting adverse events data, Deborah Zarin, the Web site’s director, told the FDA Risk Communication Advisory Committee on Nov. 12.

Third Parties Could Train Auditors for AP Inspection Program, AdvaMed Says

Janet Trunzo, executive VP of technology and regulatory affairs at AdvaMed, has suggested that the FDA allow FDA-certified, third-party auditing firms train their own investigators.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

DOJ To Expand Use Of False Claims Act To Manufacturing And AER Violations

The Department of Justice has announced that it will expand the use of the False Claims Act and that drug manufacturers that sell products to the government that do not meet specifications or that fail to report serious adverse events could face False Claims Act allegations and potentially severe penalties in the near future.

PhRMA Recommends Uniform Graphic for Online Drug Marketing

The Pharmaceutical Research and Manufacturers of America has recommended that the FDA use a uniform graphic as part of its new guidelines for online drug marketing. The graphic would link to FDA-approved prescribing information, including safety warnings. PhRMA has stated that the uniform logo would allow for the acknowledgement of risk information in formats not easily allowing for lengthy statements.

FDA Investigators Cracking Down on Devicemakers During Inspections

At a recent FDAnews webinar, Elizabeth Troll emphasized that FDA investigators are cracking down on devicemakers that are not able to produce documents during inspections and that the opportunity to get a second chance to correct observations from inspections is more limited.

FDA Issues Reminder on Cybersecurity for Medical Devices

The FDA has issued a reminder that cybersecurity for medical devices and their associated communication networks is a shared responsibility between medical device manufacturers and medical device user facilities.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

FDA Publishes Guidance on Protecting the Rights, Safety, and Welfare of Study Subjects

The FDA has announced that it has published a guidance for industry entitled “Investigator Responsibilities–Protecting the Rights, Safety, and Welfare of Study Subjects.” Comments on the guidance may be submitted at any time. More information is available at http://edocket.access.gpo.gov/2009/E9-25629.htm.

FDA Publishes Guidance on Structured Product Labeling Standard

The FDA has published a draft revised guidance for industry and reviewers entitled “SPL Standard for Content of Labeling Technical Qs & As.” The guidance is intended to assist sponsors who submit the content of their product labeling to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) using the Structured Product Labeling standard (SPL) in extensible markup language (XML). While the FDA will accept comments on the guidance at any time, comments must be submitted by December 28, 2009, to be considered before the FDA begins drafting its final version of the guidance. More information is available at http://edocket.access.gpo.gov/2009/E9-25940.htm.

FDA Issues Corrections to 2010 Fee Rates for Prescription Drug User Fee Act

The FDA has issued a notice to correct its August 3, 2009, Federal Register Notice (74 FR 38451) announcing the fiscal year 2010 fee rates for the Prescription Drug User Fee Act. More information is available at http://edocket.access.gpo.gov/2009/E9-25804.htm.

FDA Withdraws Notice of Eligibility Permitting Consideration of S. boulardii for Addition to the Monograph for OTC Antidiarrheal Drug Products

The FDA has published a notice that it has determined that Saccharomyces boulardii is more appropriately regulated as a biological product under the biologics license application system than as an OTC drug product under the monograph system, and is withdrawing its notice of eligibility permitting consideration of S. boulardii for addition to the monograph for OTC antidiarrheal drug products. More information is available at http://edocket.access.gpo.gov/2009/E9-25803.htm.

FDA Amends IND Application Regulations

The FDA has issued a notice that it is amending its investigational new drug application regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. More information is available at http://edocket.access.gpo.gov/2009/E9-26095.htm.

Mark Mansour is a partner in the firm, Bryan Cave, LLP