OCRA eNEWSLETTER      December 2004

 

Message from the Editor 

This is the final OCRA eNewsletter of the year, and what a year it has been!  2005 is certain to be as thrill-filled as this year has been (I myself can stand only so much excitement).  We hope that you have found the eNewsletter to be a useful means of education and dissemination of important and newsworthy information for the regulatory profession.  We appreciate the continued support of the membership and with your encouragement and criticism, hope to continue to provide you with the newsletter on a monthly basis.  I urge you to share your comments, concerns, and ideas for making the newsletter better.  Only with your input can we further OCRA’s mission to provide high-quality educational programs to regulatory affairs professionals in the medical products industries, and to offer a neutral forum for the exchange of information regarding issues and activities of interest to members.

 

Thanks you for your tireless support and happy New Year!

 

Paul Kramsky

 

Message from the OCRA President 

Happy Holidays to all of you!  As another year closes and as you begin to plan for the New Year, we hope you will continue to provide us with your feedback and input for future programs.  We hope that many of you were able to attend some of the OCRA programs this year and we look forward to seeing you in the New Year at the many OCRA programs that our volunteers are planning.  Continue to visit the website, read these newsletters and provide us with comments.  OCRA is your organization and we are all working together to promote worthwhile educational opportunities.  

 

Barbara Niksch

 

Update on Programs  

The Clinical Trials Program entitled "A Global Strategy for Clinical Studies: Understanding the Regional Regulations and Challenges" and held on November 16th was attended by 91 people.  Many attendees commented that they found the discussions with the panel members and the presentations from the actual U.S. and Canadian regulators very useful. Additionally, many commented on how much they enjoyed seeing OCRA address Drug and Biologic issues as well as Device issues in this program.  This program was one in a series of global clinical trial directed programs.  We look forward to your  participation in these future programs.  If anyone has any suggestions for future programs, please contact our program chair person Rusty Lusk at qualitysys@sbcglobal.net.
 

Global Initiatives for the Regulation of Medical Devices –  Join us for the full day Global Initiatives seminar on January 26, 2005, at the FDA Los Angeles District Office in Irvine.  The program will focus on the work of the Global Harmonization Task Force.  There will be an update on the work being done by each of the four study groups along with a discussion of its impact on regulations in the US and other countries.  The program will include speakers from FDA and Industry to address ISO 13485:2003 and STED (globally acceptable Summary Technical Documentation) in additional detail.  Ample time will be allocated for your questions and comments.

 

Other Educational Opportunities 

Risk Management Discussion Group

After developing a draft glossary of terms during summer 2004, the focus of the Drug Risk Management Discussion Group turned to discussions on “Criteria for Risk Acceptance” across the drug product lifecycle.  In 2005, the Drug and Device Risk Management Discussion Groups will be combined and the following topics identified for consideration:

       Risk-based cGMPs for the 21st Century

       ICH Q8 and Q9 guidance documents (currently under development)

       ISO 14971 update (currently under development)

       Framework for Risk Communication

       How to determine Risk Profiles

Please contact Tania Hoffman or Tony Chan at the email addresses below to register your interest in attending these discussions.

Tania Hoffman @ tbhoffma@USC.edu

Tony Chan @ agsm_tchc@earthlink.net

OCRA MDR Network

The MDR Network held an interesting meeting on December 1st to discuss the global harmonization efforts and the SG2 activities.  Ben Khosravi, an SG2 representative, provided an overview of the mission and activities of the SG group to date.  He provided a summary of the adverse event reporting guidelines, and reviewed activities that are currently in-progress.  If you were not able to attend the MDR Network meeting, the OCRA Global Initiatives session on January 26th will also discuss SG2 activities.

 

The next OCRA MDR Network meeting will be held in late January.  The date will be announced after Christmas - and will be published on the OCRA website.  Everyone interested is welcome to attend the meeting - and there is no charge to attend.

 

If you would like to be added to the OCRA MDR Network mailing list, please contact christineposin@msn.com.

 

New FDA Fax Numbers for MDR Reporting

Effective December 1, 2004, there were new telephone and fax numbers for the MDR/Medwatch reports:

          Telephone:   (240) 276-3000

          Fax:   (240) 276-3022 (Line 1)

                   (240) 276-3023 (Line 2)

 

Validation and Use of Excel® Spreadsheets in GLP/GMP and Part 11 Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. They are considered software and should be validated when used in regulated environment. For example the new FDA Guidance on Using Computers in Clinical Trials states for spreadsheet applications:  FDA suggests that the sponsor or contract research organization perform functional testing (e.g., by use of test data sets) and research known software limitations, problems, and defect corrections.

Most Excel® applications are non-trivial, may be widely shared and will contain significant investments in time and intellectual effort. Frequently  users of such programs are also programmers and are afraid to go through the big efforts usually associated with software and computer systems validation. Their main job is not software development or code inspection.    

FDA Center News 

From CDER

Last month, Dr. David J. Graham, a consumer safety officer with the Food and Drug Administration, shook up the Agency with charges of incompetence and misfeasance. Using colorful metaphors and an advocate's passion, he said his agency was "incapable of protecting America" against dangerous drugs. He charged that those inside the agency who had reviewed the safety of Vioxx, the painkiller withdrawn from the market in September, "did a terrible job." He called for a complete overhaul of the way the agency reviews the safety of marketed drugs. The comments outraged top officials of the agency. Dr. Steven Galson, director of the agency's Center for Drug Evaluation and Research, charged that some of Dr. Graham's conclusions "constitute junk science" and were "irresponsible."

From CDRH

The Medical Devices Technical Corrections Act (MDTCA) was signed into law by the President on April 1, 2004. MDTCA clarifies and modifies several provisions of MDUFMA pertaining to the third-party inspection program, expansion of the provision for electronic labeling and delays the effective date of Section 502(u) of the FD&C Act. The summary of MDTCA can be found on the FDA website at www.fda.gov/cdrh/mdufma/hrpt108-433.pdf. Please contact Helene Spencer at spencer@genyx.com if you are interested in further discussion of these topics at an OCRA meeting.

 

Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User Fees Under MDUFMA – This guidance provides FDA’s recommendations concerning the most timely and effective way to resolve disputes concerning FDA actions that affect the payment or refund of a user fee assessed under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). In some instances, alternative appeals processes may be available.

http://www.fda.gov/cdrh/mdufma/guidance/1303.html

From CBER

In November, FDA announced the availability of a new guidance document “Use of Symbols on Labels and Labeling of In Vitro Diagnostic Devices Intended for professional Use.”  This document provides guidance on the use of 25 internationally recognized symbols for labeling in place of text and satisfies some of FDA’s labeling requirements for in vitro diagnostics. The guidance may be obtained from the FDA website at http://www.fda.gov/cdrh/ocd/guidance/4444.html

 

Other News

Pharmaceutical and Medical Device Companies Required to Adopt Corporate Compliance Programs by July 1, 2005

On September 30, 2004, California's Governor Arnold Schwarzenegger signed dramatic new legislation that will now require pharmaceutical and medical device companies that do business in the State to develop written comprehensive compliance programs and make copies of those programs available to anyone who requests them. Companies will also be required to provide an annual written declaration of adherence to the compliance programs.  The law takes effect on July 1, 2005 and penalties for failure to comply can be quite stiff.  In addition, both private individuals and State prosecutors appear to be able to bring enforcement actions requesting civil money penalties, injunctions, and even restitution.

Under the new law, any company that manufactures, distributes, packages, repackages, labels, or relabels prescription drugs or prescription medical devices in California must develop a Comprehensive Compliance Program ("CCP").  The CCP must adhere to the U.S. Office of Inspector General's "Compliance Program Guidance for Pharmaceutical Manufacturers" (the "OIG Guidance"), which calls on companies to adopt measures to ensure compliance with the rules and requirements of federal health care programs. In addition, the CCP must also include policies for compliance set forth in the "Code on Interactions with Health Care Professionals" published by the Pharmaceutical Research and Manufacturers of America (the "PhRMA Code") in July 2002.  As with the OIG Guidance, the law requires that the CCP be updated within six months of any changes to the PhRMA Code.

 

 Regulatory Tidbits 

This final newsletter of the year draws to a close the theme which was first introduced in the October newsletter that recommended the establishment of a documented and controlled process for determining when a change is significant or not.  The November newsletter continued this theme by encouraging companies to align their regulatory decision and risk management decision-making processes.  The document and data control process is the element which should link these two processes together.  As such, it is important that an extremely robust document and data control procedure, along with a well-designed change order form, be established to ensure that changes are appropriately assessed for risk and for any applicable regulatory requirements.