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Industry: FDA Policies are Raising Threat of Drug Shortages

September 15, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

A sobering report from the American Society of Health-System Pharmacists (ASHP), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP) highlights a serious and growing drug shortage problem in this country – and the FDA is one of the big problems, according to many in the drug industry.

“This is a national security and health risk conundrum,” says former FDA reviewer and now industry consultant (and fellow Assurx blogger) Patrick Stone.

“If the pill well runs dry on our seniors or high risk folks they may expire or degrade further in health,” Patrick worries. The FDA’s “GMP controls and tightly held batch quotas are a mess. QbD will add fuel to this fire by doubling the number of drugs that don’t make it to the shelves.”

A distressing article from Marginal Revolution raises further questions about why this is happening and FDA’s role in it. “Currently there are about 246 drugs that are in short supply, a record high. These shortages are not just a result of accident, error or unusual circumstance, the number of drugs in short supply has risen steadily since 2006. The shortages arise from a combination of systematic factors, among them the policies of the FDA.”

Stone’s take: “The FDA simply doesn’t understand how many drugs are impacted by its regulations.” He challenges the agency to track that, just as it tracks 483 violations and other issues.

Editor’s Note: Watch for a new Patrick Stone blog on this topic next week.

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Filed Under: FDA Regulated, Michael Causey, Pharma/Biotech Tagged With: , , , ,

Handling a Warning Letter: If At First You Don’t Succeed…

December 10, 2010 By 2 Comments

Last year, we blogged about the most common drug and device GMP 483 items and how to respond to them in writing.  But what if your response is judged inadequate or the FDA otherwise issues a Warning Letter? First off, understand that the agency even at this point is strongly hoping you will voluntarily take the corrective action required so they can settle this case and move on to something else. They are intended to elicit voluntary correction.

However, if you fail to address the issues raised in a Warning Letter, your company can face some serious repercussions, including: recall, seizure, injunction, monetary fine, debarment, disqualification, license suspension or revocation, and prosecution.

The issuance of a Warning Letter certainly raises the stakes after a 483. The violations it contains represent concerns not only of an investigator, but of the District and/or Center Compliance Officers.

Responding to a Warning Letter

Your first action after you receive a Warning Letter should be to immediately notify top management of the letter and give them an idea of the scope of the problem. You should also contact the FDA’s District Director or Compliance Officer. In your written response to them, you should acknowledge your obligation to comply with the law, discuss the impact the issues raised will have on product quality, address any broader or systemic corrections the Warning Letter may have raised, and offer your corrective actions and timetable for completing them.

Ask to meet with the FDA. That meeting is important for a number of reasons, including:

  • Ensuring there is common understanding of GMP concerns
  • Verifying the adequacy of proposed corrections
  • Revealing if further action is planned by the FDA
  • Achieving agreement on how to proceed
  • Providing a written summary, including any clarifications and additional commitments from either side
  • Setting a timetable for periodic updates on progress

Your company can avoid “unnecessary problems” with the FDA as long as your response avoids the following: unrealistic goals, blaming everything on a lack of training, trivializing the product complaints, failing to proofread your correspondence, citing other firms’ practices as an excuse for your own, and failing to implement promised corrections.

Attorney Peter Reichard with Sheppard Mullin works closely with drug and device companies and former FDA officials. He stressed that your Warning Letter response should focus on how you are addressing the problem. “Companies have a tendency to try and explain something, but the FDA is not interested in that,” he says. “They just want to know your plan and that you followed up,” he says.

Part of that plan, Reichard says, is to put together a Warning Letter response team that goes beyond regulatory personnel. Include those involved in business and legal issues and those who keep a handle on resources and expenditures, he advised.

Avoiding Warning Letters

The only proven technique for avoiding enforcement actions [is] establishing an effective Quality System.  And the FDA defines “establish” in this instance as a Quality System that is defined, documented and implemented.

Companies that have SOPs and teams in place to handle process problems tend to do a better job of avoiding Warning Letters, agreed Adam Bloom, an attorney in Reed Smith’s Life Sciences practice.

But the absolute “worst-case” scenario is to become a repeat offender in the eyes of the FDA, he said. “If you said you would fix something, and they come back a year or two later and find the same problems,” they will view you harshly, he added.

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Filed Under: FDA Regulated, Featured, Medical Devices, Pharma/Biotech, Quality Management, Regulatory, Tamar June, Warning Letters/Recalls Tagged With: , , , ,

Savvy Compliance Strategy Part II – Checking Compliance

June 10, 2010 By 1 Comment

 

Sal Lucido, VP Enterprise Solutions, AssurX

Sal Lucido, VP Enterprise Solutions, AssurX

In Part I, we took a high-level look at a process for automating regulatory compliance management. The closed-loop process starts with Documenting your processes followed by Monitoring or Checking that your processes are being followed. Next you provide a means of Logging or Tracking any problems that may arise and then take actions to Improve. This improvement should then result in a revision to the Documented process followed by notifying or training those affected by the process improvement.  This closed-loop process, which I call the Circle of Compliance, should be used to automate the process of complying with regulatory standards.

 

The Circle of Compliance

The Circle of Compliance

 

Now lets take a closer look at the Check step. The goal of this step is to eliminate the need to manually audit a process in order to determine its effectiveness. One way to do this is by defining a Key Performance Indicator (KPI). That’s a measure of performance that is used to help an organization monitor progress to goals. For example, a company may decide to improve responsiveness by reducing the number of late tasks. A company might also set a goal for reducing violations or incidents to improve conformance to regulations or standards. You can see an example dashboard showing these two KPI’s in the diagram shown below.

Key Performance Indicators for monitoring late tasks and monthly incidents. Traffic Light indicators provide a method for quickly showing progress to goals

Key Performance Indicators for monitoring late tasks and monthly incidents. Traffic Light indicators provide a method for quickly showing progress to goals

Key Performance Indicators for monitoring late tasks and monthly incidents. Traffic Light indicators provide a method for quickly showing progress to goals.

Let’s take a closer look at this KPI dashboard. Both measurements are listed: Late Projects and Monthly Incidents. Notice that the date the measurement was made along with the actual performance data are displayed. We can see that for the month of May there were two late projects and five incidents. Then on the right we see a trend arrow (more on this below) and a traffic light, which give us a quick indication of performance to goal. Green is good and red is bad. Of course in order to set the traffic light to the correct state (green, yellow or red) we need some goals.

For example if there are less than two late projects each month the light will be green. If there are between two and four late projects we would consider that a yellow light (or caution). And if there were more than four late projects in a given month we would set the light to red.

When implemented properly, KPI’s monitor performance over a given time period (day, week, month, etc.) and provide a visual indication (traffic light, flag, etc.) of performance to goal. So let’s dig a bit deeper to better understand how to do it right.

Since a KPI measures performance over a given time period there must be historical data, trends and state changes. Let’s start with historical data. By clicking on the KPI dashboard we can see past measurements (shown below).

A report of historical KPI data shows an improving trend. An email is automatically sent in May when the light changes state.

A report of historical KPI data shows an improving trend. An email is automatically sent in May when the light changes state.

A report of historical KPI data shows an improving trend. An email is automatically sent in May when the light changes state.

We can see from the historical data that the trend is moving from bad to good and that in May there was a state change to red and yellow respectively. This system is set up to automatically send an email to the KPI Owner whenever there is a state change.

Emails are automatically sent when the light changes state. This shows a notification indicated that a things are getting worse given the light changed from green to yellow.

Emails are automatically sent when the light changes state. This shows a notification indicated that a things are getting worse given the light changed from green to yellow.

Emails are automatically sent when the light changes state. This shows a notification indicated that things are getting worse given the light changed from green to yellow.

Also if you look back at the KPI Dashboard you see the Trend arrow is green and down. Down indicates that we have fewer late projects than in the previous reporting period. The arrow is green, which indicates that this is a ‘good’ or desirable trend.

In summary, setting up Key Performance Indicators that monitor your performance to goals is a good way to ‘Check’ that your processes are working properly. It also eliminates the need to perform manual audits of
a given operation reducing labor costs. The next step in this closed-loop process is ‘Tracking Problems’.

Next time: We’ll take an in depth look at the ‘Tracking Problems’ step.

Read Read Part I, III and IV.

Sal Lucido is Vice President, Enterprise Solutions at AssurX, Inc. You can follow him at http://twitter.com/ComplianceTips

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Filed Under: Electric Reliability, FDA Regulated, Regulatory, Risk Management, Sal Lucido Tagged With: , , , , ,

Savvy Compliance Strategy Can Ease GMP, Electric Reliability Regulatory Challenges

June 2, 2010 By 5 Comments
Sal Lucido, VP Enterprise Solutions, AssurX

Sal Lucido, VP Enterprise Solutions, AssurX

The primary function of the compliance department is to ensure that the company complies with all of the applicable regulations, rules, and laws. Regardless of industry (life science, energy and utilities, financial services, etc.) this is a universal charter.

As someone who serves customers across many heavily regulated industries, I think I’ve got a unique perspective — and I’d like to share some of what I’ve learned along the way in the hopes that it helps you in some small way .

One particularly useful tool I see used across all industries is what I call the ‘Circle of Compliance’. Before I explain this concept, let’s take a deeper look at the job of the compliance department.

As I’ve already mentioned, the compliance department is put in charge of ensuring that all applicable compliance requirements are met. For example U.S. medical device companies must comply with the FDA’s Good Manufacturing Practices (GMP). Regulation 21 CFR Part 820.90 states that each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. So the compliance department must determine if their company follows this process.

This is not so different from a U.S. power company that owns transmission lines. They must comply with Reliability Standard FAC-003 that mandates a clearance be maintained between transmission lines and vegetation. It also requires the company to report any vegetation related outages. These are different industries and different regulators (FDA, NERC), but each has the same fundamental task.

So how does the compliance department go about ensuring these regulations are met? Typically they audit the company for compliance. If there is a gap between the requirement and current practice, they work with the appropriate departments to close the gap. Take a look at this illustration for a visual representation of this ‘push’ exercise.

Relying on the Compliance Department to close compliance gaps is a time consuming, never-ending job…

Relying on the Compliance Department to close compliance gaps is a time consuming, never-ending job…

You can see from the illustration that this is a manual task. The problem is that it is a time consuming, never-ending job. As soon as the compliance department shifts their attention to another area of the company, compliance gaps can (and usually do) reappear. This is then addressed with ‘periodic’ audits. What we end up with is an endless and expensive merry-go-round of audits and fixes.

The solution? Set up a process that continuously ‘pulls’ the operations towards the regulations. I’ve illustrated this type of system below.

…it is better to implement processes that automatically and continuously close compliance gaps.

…it is better to implement processes that automatically and continuously close compliance gaps.

You can see the advantage of this system from the illustration. It does not require the constant and repeated attention of the compliance department.

So what is this process? I call it the ‘Circle of Compliance’ as illustrated below.

The Circle of Compliance

The Circle of Compliance

In a nutshell, this is a closed-loop corrective/preventive action process. While you might recognize the process as it relates to quality systems, you may not have considered its application to the job of regulatory compliance.

This is how the process works: Let’s look at the U.S. power company that must ensure that trees are kept away from transmission lines. Of course the compliance group would first check to make sure the vegetation inspection and removal procedure is ‘Documented’ adequately.

Next the compliance group would see if there is a ‘system’ in place for monitoring that the process remains effective. This is the ‘Check’ part of the process. Also they would ensure that there is a process for documenting problems such as vegetation related outages. Most compliance departments do a good job of auditing these two steps, but it is crucial that the next two steps are completed.

Any and all problems with the vegetation monitoring system must be ‘Tracked’. This means they must be documented in a system that links directly to the next step: Improve. All problems must be looked at to determine how the problem occurred and how the system can be ‘Improved’ to prevent reoccurrence. This improvement must then result in a change to the ‘Documented’ process followed by retraining of the workforce to the new process.

If implemented properly this closed-loop ‘Circle of Compliance’ will save the company time and money while improving its ability to comply with industry regulations.

Next time: I’ll explore each of these steps (Document, Check, Track and Improve) in more detail.

Read Part II, III and IV.

Sal Lucido is Vice President, Enterprise Solutions at AssurX, Inc. You can follow him at http://twitter.com/ComplianceTips

 

 

 

 

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Filed Under: Electric Reliability, FDA Regulated, Regulatory, Risk Management, Sal Lucido Tagged With: , , , ,