Food And Drug Administration (FDA) Working On Y2K Pharmaceutical And Biotech Industry Awareness (Report)

Its like a peek inside the window on what one of the alphabet agencies is DOING with their industry group for Y2K. Why am I not feeling good about it? -- Diane

SUMMARY COMMENTS:

... some of the most serious outcomes of the Y2K problem could be product shortages and failures.

... the FDA has "extensive experience and infrastructure" for handling emergencies and making the public aware of them.

... The spectrum of potential adverse consequences of Y2K problems ranges from minor to major.

... Product shortages may result from a manufacturer's:
(1) internal Y2K problems (e.g., a production machinery malfunction);
(2) external Y2K problems (e.g., a supplier's inability to ship components or a common carrier's inability to operate) or,
(3) a combination of the two.

... However, shortages can also be artificially created by product stockpiling, resulting from consumer perceptions and panic concerning future product availability.

[Ouch !!! Blame the public.]

... Y2K is somewhat unique in that it has the potential to create serious problems for numerous manufacturers simultaneously.

... there are very few foods that are considered essential, whereas certain drugs are medically essential and there may not be alternative suppliers. ... have major concerns about continued performance of automated medical devices and blood establishment software.

... FDA's regulatory authority allows us to address Y2K problems when they cause products to be adulterated or misbranded (e.g., incorrect expiration dating); however, we have limited regulatory authority to address Y2K problems before they occur...

[Oy vey!]

... the Agency anticipates an increase in the number of product shortages or failures due to Y2K problems.

... FDA's Y2K regulatory rapid response planning is being done by each of FDA's individual Centers (Devices, Drugs, Biologics, Foods, and Veterinary Medicine) and ORA (Office of Regulatory Affairs). Each Center will determine the level of detail needed for its own Y2K rapid response plan. ... planning will vary significantly from one Center to another.

... The Agency has been providing its industries with information and guidance on the Y2K issues. ... have issued Y2K letters to their industry trade associations, making clear FDA's expectations for the industry to address the Y2K issue. Multiple letters have been issued ... directly to individual manufacturers ... to approximately 300 pharmaceutical manufacturers that were identified as sole source suppliers of drugs, including biologics.

[Letters??? Wow! That should trigger Y2K action.]

... USDA is the lead agency for the Food Supply Y2K Working Group ... (i.e., Office of the Under Secretary Food Safety, Food Safety and Inspection Service, Animal and Plant Health Inspection Service, and Cooperative State Research Extension and Education Service) are members.

... This cooperative effort targets an industry audience (e.g., national trade organizations such as National Food Processors Association, Grocery Manufacturers of America, American Frozen Food Institute) that deals with FDA and USDA regulated products.

... FDA can expect to be presented with situations where, because of a Y2K failure, the manufacturer is producing a product that does not or cannot comply with FDA regulations.

... Any decision to relax or suspend FDA regulatory requirements must be limited in order to: (1) minimize risk of public exposure to defective or misleading products;
(2) encourage prompt and thorough completion of Y2K remedial measures; and,
(3) minimize creation of legacy problems that will need prompt correction post-Y2K.

... (Agency actions should not cause firms to view the situation as a convenient way to dispense with unpopular requirements for an indefinite time.) ... A risk assessment process ... to determine whether a product that is adulterated, misbranded, or otherwise violative of FDA law

24 February 1999

TEXT: FDA IS WORKING WITH INDUSTRY TO PREPARE FOR Y2K

http://www.usia.gov/current/news/latest/99022401.glt.html?/products/washfile/newsitem.shtml

(Haggard cites experience handling emergencies) (1820)

Washington -- Despite the limited authority of the U.S. Food and Drug Administration (FDA) to require pharmaceutical and biotech industries to address Y2K problems before they occur, the FDA is alerting regulated industries on how to prepare for the year 2000 date change.

In a joint government/industry forum, David Haggard, director of the FDA's Division of Compliance Policy, said some of the most serious outcomes of the Y2K problem could be product shortages and failures.

Through correspondence, meetings, workshops and guidance documents, the FDA is reminding manufacturers of biological products of their responsibility to assure that the Y2K problem does not adversely affect product safety, efficacy or availability. The FDA is also working with other agencies to address the problem. In the food sector, for example, the U.S. Department of Agriculture is leading the way.

Haggard said the FDA has "extensive experience and infrastructure" for handling emergencies and making the public aware of them. The FDA itself is currently 90 percent Y2K compliant and plans to have its systems completely Y2K-ready by March 31.

Following is the text of Haggard's remarks:

(begin text)

FDA's Day One Rapid Response Plan
By David K. Haggard, Director Division of Compliance Policy

Presentation to HHS Outreach Sector

February 17, 1999

Impact of Regulated Industry's Problems

Industries regulated by the Food and Drug Administration (FDA) have an obvious vested interest in their own continued operation, and are highly motivated to solve the Year 2000 (Y2K) problem before it has any adverse impact on their operations or products.

In spite of industry's efforts, the Agency must be prepared to deal with problems associated with regulated industry noncompliance with Y2K. The spectrum of potential adverse consequences of Y2K problems ranges from minor to major. From FDA's perspective, one of the most serious concerns is the possibility of product shortages. Product shortages may result from a manufacturer's: (1) internal Y2K problems (e.g., a production machinery malfunction); (2) external Y2K problems (e.g., a supplier's inability to ship components or a common carrier's inability to operate) or, (3) a combination of the two. However, shortages can also be artificially created by product stockpiling, resulting from consumer perceptions and panic concerning future product availability.

Y2K is somewhat unique in that it has the potential to create serious problems for numerous manufacturers simultaneously. Depending upon the number and seriousness of Y2K problems, FDA could be seriously impacted by both regulatory problems and shortage situations. Such shortages, if they were to occur, pose different risks for different commodities. For example, there are very few foods that are considered essential, whereas certain drugs are medically essential and there may not be alternative suppliers. In addition to concerns about continued product availability, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have major concerns about continued performance of automated medical devices and blood establishment software.

FDA's regulatory authority allows us to address Y2K problems when they cause products to be adulterated or misbranded (e.g., incorrect expiration dating); however, we have limited regulatory authority to address Y2K problems before they occur or to require manufacturers to become Y2K compliant before it is necessary.

FDA's Capabilities in Dealing with Regulated Industry Y2K Problems

The Agency has extensive experience and an infrastructure for handling emergencies requiring the Agency to quickly alert the public and oversee the removal of dangerous products from the market. Such actions are frequently necessary when marketed products have not met their specifications, or there have been incidents of tampering. Manufacturing production problems, recalls or sometimes regulatory actions have resulted in product shortages. The Centers have procedures and experiences in dealing with product shortages to mitigate the problem. However, the Agency anticipates an increase in the number of product shortages or failures due to Y2K problems.

A list of FDA Y2K contact persons both in headquarters and in the field is being developed and made available throughout the Agency. These contacts, knowledgeable of the status of Y2K preparations in their offices, provide liaison for further Y2K rapid response planning. As industry Y2K problems are identified, these contact persons are responsible for facilitating intra-Agency coordination and communications to address the issues.

FDA's Y2K regulatory rapid response planning is being done by each of FDA's individual Centers (Devices, Drugs, Biologics, Foods, and Veterinary Medicine) and ORA (Office of Regulatory Affairs). Each Center will determine the level of detail needed for its own Y2K rapid response plan. Given the variable impact of Y2K on various industries, the level of detailed planning will vary significantly from one Center to another. Each Center is preparing a Y2K regulatory rapid response plan and regulatory strategy to deal with a wide range of possible product shortage problems and product failures. Center plans are to be completed by March 31, 1999, and then shared with ORA for its rapid response planning.

The rapid response plans will identify key and knowledgeable Y2K persons in each Center and ORA who will respond to Y2K related product shortages and failures and the type of field coordination and support needed. Each plan will identify medical, compliance, and business liaison personnel, as appropriate, along with ORA representation or liaison to ensure efficient and responsive field support.

Testing of the response plans will be coordinated to minimize duplication of effort and disruption of other field activities. All testing is to be completed by Labor Day (September 6) 1999.

FDA's Efforts to Ensure Regulated Industry Compliance

The Agency has been providing its industries with information and guidance on the Y2K issues. CDER and CBER have issued Y2K letters to their industry trade associations, making clear FDA's expectations for the industry to address the Y2K issue. Multiple letters have been issued by CDRH (Center for Devices and Radiological Health) directly to individual manufacturers, and recently CDER issued a follow-up Y2K letter to approximately 300 pharmaceutical manufacturers that were identified as sole source suppliers of drugs, including biologics. CDRH and CBER have also issued industry guidance concerning their regulatory approach and expectations. CVM (Center for Veterinary Medicine) will issue a Y2K letter to their industry in the near future.

CFSAN (Center for Food Safety and Applied Nutrition) is working with the Department of Agriculture (USDA) to address Y2K concerns in the food sector. USDA is the lead agency for the Food Supply Y2K Working Group, and CFSAN's primary activity has consisted of providing input into USDA's approach. FDA and several USDA agencies (i.e., Office of the Under Secretary Food Safety, Food Safety and Inspection Service, Animal and Plant Health Inspection Service, and Cooperative State Research Extension and Education Service) are members. This cooperative effort targets an industry audience (e.g., national trade organizations such as National Food Processors Association, Grocery Manufacturers of America, American Frozen Food Institute) that deals with FDA and USDA regulated products. Using USDA's infrastructure to implement the Y2K contacts, the message of Y2K awareness is getting to the desired audiences. FDA has linked its Y2K web site directly to the USDA Y2K web site. The information on the web site is "Food Industry" directed rather than USDA or FDA specific. To make best use of their limited resources, CFSAN plans to continue their current approach.

Further, FDA has used direct correspondences, speeches, public appearances, and meetings to further convey its position and expectations on Y2K compliance. In addition, the Agency has provided a Y2K link on its FDA Home Page Internet site (www.fda.gov).

FDA can expect to be presented with situations where, because of a Y2K failure, the manufacturer is producing a product that does not or cannot comply with FDA regulations. Any decision to relax or suspend FDA regulatory requirements must be limited in order to: (1) minimize risk of public exposure to defective or misleading products; (2) encourage prompt and thorough completion of Y2K remedial measures; and, (3) minimize creation of legacy problems that will need prompt correction post-Y2K. (Agency actions should not cause firms to view the situation as a convenient way to dispense with unpopular requirements for an indefinite time.) Decisions regarding enforcement discretion to allow continued marketing of such products are to be based on public health considerations and risk. A risk assessment process must be in place to determine whether a product that is adulterated, misbranded, or otherwise violative of FDA law may need to be made available to meet critical needs, especially where it may be the only product that can meet those needs. The Division of Compliance Policy has drafted a Y2K Compliance Policy Guide (CPG) for FDA staff and industry to understand FDA's regulatory expectations both before and after January 1, 2000. This CPG is in clearance now and when approved, will be posted on FDA's Y2K Web Site and available to the public.

In partnership with the Veteran's Health Administration, FDA has established the Federal Y2K Biomedical Equipment Clearinghouse. Currently it is a Web-based searchable database of Y2K noncompliant devices and scientific/research equipment. The Clearinghouse will be expanded in the next several months to also include specific information on Y2K compliant equipment. The Clearinghouse is intended for use by Health care facilities in doing their own Y2K readiness assessment.

FDA's Division of Emergency and Investigational Operations (DEIO) issued a memo to the field offices instructing field investigators to provide information on the Y2K status of FDA's computer systems, and other Y2K information they can provide to any manufacturers who need it. This memo includes a general description of the Y2K problem, how it can impact automated manufacturing and quality assurance operations, and how investigators should conduct both their pre- and post-Y2K inspectional activities. For example, the memo emphasizes that investigators are not to evaluate Y2K readiness, but in the event that manufacturers have made changes to the processes or equipment they are currently using in order to become Y2K compliant, investigators are encouraged to check that the changes were made and evaluated in accordance with the firm's procedures and the changes were properly validated.

FDA's Continuing Efforts to Monitor Y2K Regulatory Activities

Following their meeting on October 8, 1998, the Compliance Policy Council formed a Year 2000 (Y2K) Working Group. The Y2K Working Group was established to develop and coordinate Agency regulatory activities regarding Year 2000 issues concerning FDA regulated industries. The Working Group has met approximately once per week since late October to discuss and formulate strategies. The Group will:

-- establish milestones for development and completion of policies, rapid response plans, reviews, testing, and staff training,

-- Center rapid response plans to be completed by March 31, 1999,

-- ORA's rapid response plans to be completed by June 31, 1999,

-- validated and tested together with Center plans by August 31, 1999.

-- monitor completion of all Y2K tasks.

-- report regularly to Agency management regarding progress and preparations.

(end text)

-- Diane J. Squire (sacredspaces@yahoo.com), February 25, 1999