In Washington, D.C., experts tracking the political shifting sands often advise you to watch what someone does, not what they say. Applying that to the FDA suggests the agency is starting to take risk management enforcement a bit more seriously.

Here’s a good example. Earlier this week (Feb. 16) the agency approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs) manufactured by Amgen Inc. The company’s risk management program or Risk Evaluation and Mitigation Strategy (REMS), requires health care professionals to provide their patients receiving an ESA with a Medication Guide that contains information for patients on how to safely use a drug.

And earlier this month, the agency requested a 23% hike in its budget to help it more aggressively pursue food, drug and device safety (plus its new tobacco initiative).

More action and more dollars could add up to a more active FDA in 2010.

Make sure to read our previous post: Risk Management Matures Beyond the Spreadsheet

Numbers don’t lie. Reviewing the year-end numbers for FDA’s CDRH electronic submissions (AS2 Electronic Submissions Gateway) provides some eye popping stats.  This is an early indicator that electronic medical device reporting submissions have significantly increased over 2008, and certainly suggests they’ll rise even faster this year after the final rule is published.

Comment period on the draft guidance ended November 2009. The final ruling is expected within weeks. According to some FDA insiders, many were relieved the agency wasn’t overwhelmed with comments (slightly over two dozen comments were filed), and the ones received were definitely “workable”.

So, what did 2009 numbers look like?

As the chart shows, early 2009 got off to a slow start, but picked up significantly in the fourth quarter of the year.

But when comparing 2008 vs. 2009, total submission numbers jumped from 4,619 to 21,296. It’s apparent that the device industry has picked up the pace when it comes to electronic submissions to FDA. And if this isn’t a wake up call for device companies to move away from paper 3500A submissions to eMDR, we don’t know what is.

We’ll be keeping a close eye on this through 2010.

WHEN: Thursday, January 28, 2010 – 10 am – 2pm (Pacific)

REGISTER: https://www2.gotomeeting.com/register/554360930

WHO SHOULD ATTEND: All AssurX Energy/Utility Customers

AGENDA:

How to Manage NERC CIP Workflows & Documentation
NERC CIP Compliance Management – CIP-002 thru CIP-009 reached the Auditably Compliant stage July 1st, 2009. In this talk we will take a look at best practices for managing CIP workflows including configuration change management and process/plan review workflows.

How to Manage a NERC Compliance Framework
Part of a NERC audit includes submitting information about how your internal documentation (i.e. procedures, policies, etc.) relates to each applicable requirement. This presentation will demonstrate how CATSWeb ER can be used to establish this compliance framework.

NERC Standard Update Service
View how the NERC Standard Update Service is used to import new NERC standards and file attachments into your CATSWeb ER system.

Self Certification
Using the new CATSWeb 16Q Service Pack rules engine, view how your self-certification preparation process can be automated to create and assign all Gap Analysis records and monitor when all Gaps have been completed.

Using CATSWeb for PRC-005-1 Compliance
Demonstration of CATSWeb configured as a standalone system as well as an integration hub with various Work Order Management, ERP and Test Systems assuring that assets which effect the BES are in PRC-005-1 compliance.

Taking your CATSWeb ER system beyond your expectations
An opportunity to learn how companies use CATSWeb ER to steamline the management of documents, assets, approvals, certifications, testing, exceptions, etc.

Sessions will last anywhere from 20 – 45 minutes each and will be followed by a 5 – 10 minute Q&A, as well as a midway break. This four hour event will be recorded and available for replay shortly afterwards. Presentations will be available for download immediately following the event.

The early part of the 21st century was a tough time for the FDA. Its budget was curtailed, it lost some important personnel, and the word “acting” kept appearing on people’s business cards.

But 2009 just might be going down in history as the Year of the FDA Turnaround.

In October, the agency announced a long-overdue hiring binge that signals an even stronger FDA is on tap for 2010.

Watch for the agency to get a bigger budget in the coming years – though much of that emphasis will be on the food side and perhaps less on the drug and device side. For FY 2010, the FDA requested a total budget of $3.2 billion. This amount is $511 million more than FY 2009 and represents a 19 percent increase — the largest ever in FDA history. They won’t get it all, but they’ll probably come close.

Here are some other FDA highlights in a big year:

FDA Finally Gets Tobacco

It took years of lobbying and a new President, but in June 2009 the FDA was given the power to regulate tobacco products. This is a huge victory for the agency. It remains to be seen how the FDA will use this new power, but its surge of activity in the second half of 2009 suggests they want to seize the initiative.

Lawrence Deyton, M.S.P.H., M.D., joined the U.S. Food and Drug Administration (FDA) on Sept. 14, 2009, as director of the agency’s new Center for Tobacco Products. He hit the ground running.

“Our objective is to use the best available science to develop and put into action effective public health strategies to reduce the enormous toll of illness and death caused by tobacco products,” Deyton said .

Deyton was also asked how the tobacco regulation differs from FDA’s regulation of drugs or medical devices?

“FDA’s regulatory role for drugs and medical devices is usually based on a safety and effectiveness standard. The tobacco act establishes a new standard: to regulate tobacco products based on a public health and population health standard.

Deyton noted that when FDA gets an application for a new drug to treat a disease, the agency normally considers studies of patients who have the disease. ”But when we get an application for a new tobacco product, the law tells us we have to consider whether permitting the product’s marketing protects the public health and we have to evaluate the effects of the product on the population as a whole. We’re directed to consider both users and nonusers, and whether our action might encourage people who don’t use tobacco products to begin using them, or encourage people who might otherwise quit to continue using them.”

Bottom-line: It was a huge turf battle victory for the FDA and increases the agency’s overall regulatory clout.

Risk Communications

The agency also took big strides forward in how it gets the word out to industry and the public regarding risk. In its Strategic Plan the agency spelled out its perceived role in communicating the risks of regulated product use, defining risk communication anew for a 21st century in which evolving technologies have enabled increased patient and consumer involvement in managing their health and well-being. The document defines the three key areas (science, capacity, and policy) in which strategic actions, in collaboration with relevant domestic and international stakeholders, can improve the generation, dissemination, and regulation of risk communication about regulated products. It also identifies and details 14 specific strategies.

“FDA is showing its commitment to the goals of the plan not just by identifying the strategies it will implement, but also by identifying over 70 actions the agency plans to take within the next few years to improve risk communication,” it says in the Strategic Plan. The document also identifies 14 of those actions that FDA plans to accomplish within the next 12 months.

Clearing Up Transparency

Echoing an Obama campaign promise to make government more open and accountable to taxpayers, the FDA also walked the walked and talked the talk with its new “transparency”  initiative with public meetings in June and November. The agency also opened a blog that, so far, has had a fair amount of uncensored comment both pro and con about agency performance.

Here (Finally) Comes the eMDR Guidance

In August, the FDA unveiled their proposed guidance for ultimately mandating electronic submission of mandatory adverse event reports. It took a long time to come to fruition, and some are lobbying the agency to push it back another year or two, but the simple fact that it was released was a big deal in 2009.

Guidance on Presenting Risk Info

Before unveiling the eMDR rule, the agency also issued  in May the important draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion. The guidance is important on several levels, but perhaps the most important is that it addresses factors the FDA considers when evaluating ads and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations.

In doing so, it cleared up a lot of confusion in the industry and signaled a revitalized FDA that was on the way back.

Putting The ‘Food’ Back In Food & Drug Administration

Responding in part to pressure from Congress and consumer groups over beef and other food contamination recalls, the FDA also revitalized its food enforcement in 2009, and this is also an area where the smart money says they’ll be even more active in 2010. In September, the agency capped a number of new food initiatives by unveiling a new reporting system that gives the agency new enforcement teeth when it comes to the food chain.

Here’s a prediction: FDA historians of the future are probably going to see 2009 as the year the agency picked itself up off the ground and started to flex its regulatory muscle again.

Ken Miles, a 28 year veteran of the FDA, is today a widely-respected industry consultant to the medical device industry. He draws on his extensive experience to help firms effectively and efficiently comply with FDA requirements. Ken’s expertise includes evaluating Good Manufacture Practice (GMP) and Good Laboratory Practice (GLP) compliance, Quality System Regulations, and QSIT certification inspections (Management, Design, Process Controls, and CAPA).

In this multi-part series, we talked with Ken about FDA inspections, CAPA, quality systems, audits, training and more.

Q: When you were with the FDA, what did you look for during onsite inspections at medical device facilities?

A: What I primarily looked for was a robust quality management system that covered all of the key areas: CAPA, internal quality audit findings, training, MDRs and complaints, supplier quality, etc.   Supplier audits are also very important, and they should always tie back into CAPA and management review findings.

Q: You mention training as part of the overall quality management system –  what kind of problems did you see in that area?

A: The most common problem with training is that programs are often inadequate. Oftentimes procedures are either nonexistent or very poorly written. You need to have stringent management commitment and oversight, while also removing irresponsible people who can seriously damage the business. Procedures, management review and training are the primary areas that should generally be addressed through a CAPA program to make it work.

Q: Digging deeper, what were the CAPA-related issues you saw most often during inspections?

A: The one thing I saw often was that companies did not prioritize their CAPA items. You need to prioritize them using a risk-based approach. The highest priority ones should be put at the top of the list. Sounds like an obvious thing, but a lot of companies just throw all CAPA related issues into one bucket with no priority or even closure dates. If you don’t have some sort of prioritization system, you might become weighed down with too many assignments with no end in sight. Prioritize by low, medium and high priority, as well as severity of consequences. That would also imply that you have a target date, or closure date once you implement that program. A lot of companies don’t do that.

Q: You stress the importance of prioritizing and setting due dates for CAPA. Can you give us some examples of what you looked for during your inspections?

A: Medium and serious CAPA issues should be closed out within 30 or 90 days at the most. I’ve seen situations where CAPAs are still hanging out there after two or three years! And I’ve even some that have never closed or resolved! In certain situations, I’ve also seen CAPAs that don’t even have a closure date. Unfortunately, that’s typical of spreadsheet based CAPA systems.

In the next part, we will delve deeper into actual situations, and discuss some of the more egregious things that Ken Miles experienced as an FDA inspector.

Click here for more detailed information about CAPA.

In a recent FDA presentation Foster City, CA, Mark Roh, Regional Food and Drug Director outlined the most common cited 483 items for both pharma and med device companies:

The most common Drug GMP FDA-483 (observational) items:

• Responsibilities and procedures of the Quality Control unit are not in writing
• Written procedures are not followed
• Control procedures not established
• Inadequate specificatons
• inadequate written procedures
• Inadequate failure analysis

The most common Medical Device GMP FDA-483 (observational) items:

• Deficiencies in complaint file system
• Inadequate CAPA procedures
• Lack of written MDR procedures
• Corrective and preventive actions not documented
• Inadequate process validation

This doesn’t mean you won’t be cited for anything not listed in the bullet items or nabbed for all of the above. These are the most common observations cited by FDA personnel during an inspection. So now you may want to go back and take a good hard look at your SOPs, quality management system, CAPA process, complaint handling/MDRs as well as your validation documentation. Obviously training your personnel in these procedures and processes is also key.

Of course, everyone’s goal is not to end up here…

Also, you may want to check out our previous blog entry “Don’t Ignore 483s…it’s in Your Best Interest to Respond in Writing“

The concept of implementing SaaS is moving ahead quickly, especially in the medical device arena. Perhaps that shouldn’t be surprising; most industry experts say that device firms tend to be a bit more innovative when it comes to embracing new technologies.

That may be why Angiotech made the decision to go with AssurX’s OnDemand (SaaS) model as opposed to on-premise implementation for their global complaint handling system. Angiotech is a global specialty pharmaceutical and medical device company that discovers, develops, and markets innovative technologies and medical products primarily for local diseases or for complications associated with medical device implants, surgical interventions and acute injury.

AssurX’s CATSWeb system is already rolled out across four facilities – three in the US and one in Puerto Rico – with Europe expected by the end of 2009.

Larry Murphy, Senior Manager, Corporate Quality, was part of the team that made the decision to go with the SaaS model because they needed to get up and running quicker.

“We got the blessing of the IT group after they reviewed the AssurX system and were able to get answers quickly about the level of security and support,” Murphy said. “As far as the users are concerned, they really like having everything centralized, including the reporting capabilities. We have significantly improved our efficiency and productivity,” added Murphy.

Prior to implementing an automated complaint handling system, various divisions of Angiotech were using either paper-based systems or homegrown Access database applications. Now the company-wide system using CATSWeb allows them to process complaints in a more structured and standardized manner that provides a much higher level of quality of information as well as the ability to track progress using metrics and dashboards.

Future plans include expansion of the current process and perhaps implementing electronic medical device reporting (eMDR) somewhere down the line.