The FDA’s New “Get Tough” Enforcement Policies

January 15, 2010

On August 6, 2009, FDA Commissioner Dr. Margaret Hamburg publicly announced the FDA’s new enforcement strategy. This strategy involves 6 new policies that went into effect on September 15, 2009 – what are the policies, and what do they mean to you?

1. The FDA will set post-inspection deadlines. Firms will generally have no more than 15 working days in which to respond to serious violations before the FDA moves ahead with a warning letter or enforcement action.

Impact: it is important to note that there is no regulatory requirement to respond to 483 observations. Therefore, a warning letter will not be issued just because you didn’t respond in a timely manner, or respond at all. However, if the FDA feels that the violations are serious and want to issue a warning letter, they will only review your responses to defend yourself (state your case) if they are sent within 15 days.

2. The FDA will take responsible steps to speed the issuance of warning letters. FDA’s Chief Counsel will limit warning letter review to significant legal issues, therefore allowing most enforcement letters to move forward through a more streamlined process.

Impact: since you have only 15 days to state your case through responses as stated in policy #1 above, the speed at which the FDA operates internally has very little impact on the actual outcome other than timing. Historically, the longer the FDA took, the more opportunity you had to send in multiple responses and proof that you had implemented what you said you were going to implement. However, once the FDA heads down the path of warning letter, there is very little you can do now to stop the train.

3. The FDA will seek to work more closely with our regulatory partners to develop effective risk control and enforcement strategies. This action is mainly focused on the food industry, where local, state, and international offices have more authority than the FDA to take action quickly.

Impact: hopefully greater safety for us as consumers once suspect food is out in the market.

4. The FDA will prioritize enforcement follow-up. After a warning letter or product recall, the FDA will make it a priority to follow-up with appropriate action.

Impact:The FDA will be coming in sooner to verify that you have done what you said you were going to do, and that your actions were effective. There is less time to implement a corrective action and see the benefit of that action. Corrective actions need to be thorough.

5. The FDA will be prepared to act swiftly and aggressively to protect the public. The FDA will consider immediate action without the issuance of a formal warning letter when necessary.

Impact: Not necessarily new, just greater emphasis and perhaps greater empowerment to the Districts to act when they feel it is necessary. For example, TEVA Animal Health received a consent decree July 2009 without a warning letter being issued first.

6. The FDA is developing a formal warning letter “close-out” process. If the FDA can verify the effectiveness of corrective actions (typically through reinspection), then a close-out letter will be issued to signify closure of the warning letter issues.

Impact: clear indication to industry and investors that the FDA truly is satisfied with corrective actions and that warning letter issues are resolved. The problem might be if there are resource constraints for the FDA getting back to your facility to verify, then it might send the wrong message to the rest of the industry.

The best line of defense is to have excellent quality oversight now to ensure that the systems you have in place are compliant, functional, and effective. Then you won’t have to worry about getting a warning letter in the first place. Easier said than done, but more critical now than ever.

 

 

Tags: FDA , FDA responses , FDA warning letters , FDA enforcement action

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Our Vulnerable Supply Chain

October 02, 2009

What is going on with our Supply Chain? A better question is: what isn’t going on with our supply chain!

Many Americans are aware of the quality concerns of products coming from China, and perhaps they are aware of the quality issues related to India. Outside of our industry, there have been examples that were at the forefront of the news, such as the safety of children’s toys related to lead-based paint. As patients, we Americans assume that the issues related to pharmaceutical products are rare and that our medicines are safe. The infamous thought of “it can’t happen to me” calms our fears.

How accurate is our perception? Unfortunately, the issue of counterfeit medicine is more prevalent than most Americans are aware of….and certainly, most Americans don’t realize that the U.S. supply chain plays a large role in the problem. In a recent presentation Katherine Eban, author of Dangerous Doses, revealed the results of three years of her research into illegal trade of legal medications originating and ending in the United States. Eban described the real scenario where felons who were convicted of trafficking illegal drugs are able to obtain legitimate licenses from the State of Florida to run and operate a “pharmacy” in that state. The Florida government only requires that an individual fill out a 2 page form, which is then accepted without a background check or facility assessment. As a result, these “pharmacies” are mobile homes, basements, and garages owned by the felons or their families.

So the convicted felons own their own legal “pharmacies”, but how do they break into the legitimate trade of legal drugs? Here is one example. The felon illegally buys prescription medication from Medicare patients or veterans, then re-labels the medication for a higher strength (even though the content is still the same). The felon then sells these drugs back into the legal prescription drug market through wholesale distributors, who then sell it to your pharmacy in your neighborhood. Eban described how a felon in Florida purchased Epogen 2,000 unit vials ($38 per vial) from VA patients, relabeled the vials as Epogen 40,000 units ($643 per vial) and sold it back into the legal market. This vial made it up to the New England states where a 16 year old boy received it from his local CVS.

In other words: yes, the majority of counterfeit drugs come from China, followed by India, but it is happening in the U.S. as well.

What can we as an industry do about this? This is difficult to answer. Some will say to improve the transparency of the supply chain (pedigree), audit the supply chain, don’t put original COA data on new company letterhead, test every drum of every product/excipient beyond identity testing, and don’t rely on paper audits. However, none of these alone will solve the problem, and although it would be greatly reduced, even all of them combined won’t completely stop criminal activity.

1. Imagine the cost of implementing all of these actions. For many small companies, this would be enough to drive them out of business.

2. Suppliers can’t manage audits by every client, so how can on-site audits be conducted?

3. Closed portions of DMF’s greatly hinder the transparency.

So again, what can we do? The answer is that the industry needs to address this as an Industry. There are real solutions that can be implemented if we work together. This is not an option, but rather a requirement to protect patients around the world – including on your street and in your house.
As groups such as IPEA, RX-360, and the FDA explore new concepts, such as a 3rd party auditing strategy, the industry needs to support these efforts and participate.

 

 

Tags: IPEA , RX-360 , FDA , illegal trade , supply chain , pedigree , pharmacies , counterfeit medicine , Katherine Eban , Dangerous Doses , pharmaceutical products

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TrendWatch: A New Look at 3rd Party Audits

August 04, 2009

Colleagues keep asking me why “3rd Party Auditing” is buzzing around the industry, and are trying to understand what this is all about. By definition, having consultants conduct audits of your contractors is a “3rd Party Audit”. But this isn’t new, so why all the hype? The buzz surrounding this issue has to do with a new concept, and one that I personally feel has to take hold within our industry. Imagine two scenarios:

• 3rd Party Audit: your company sends you to conduct an audit of your contractor. Your company has legions of auditors to conduct all of the audits expected, and every contractor has a department dedicated to hosting audits. While at the contractor’s facility, you are only able to assess systems by reading SOPs, reviewing metrics for trends, and reading documents pertaining to your product. While on tour, you are not even able to look into a stability chamber, because you might see a competitor’s product in there. You assess the system adequacy without being able to see the entire system. You feel that your auditing abilities meet FDA expectations, because you have been trained by your company and you have been auditing for years.

• 3rd Party Audit – new concept: a legion of independent 3rd party auditors are certified against a pre-determined standard. A standard does not currently exist, but if a group of industry experts identified a standard, then it would have to be better than what the vast majority of the industry is using to judge if auditors are suitable or not (which is mostly based on opinion). These auditors would audit contractors, and would have the ability to assess all systems across the board. The audit reports would be written with identifying information removed. Client companies could then purchase the reports in place of having to conduct the audit themselves.

Option 2 mitigates the tremendous variability in auditor performance – it does not eliminate the variability, because of the ever present human factor. It would greatly reduce the financial burden on both sides, as the innovator companies would no longer need a legion of auditors, and the contractors would not have to have entire departments dedicated to hosting audits. More importantly, however, is the current consequence of contractors hosting so many audits – meeting client demands. Although a contractor may have had a compliant system in place, every client asks the contractor to “tweak” the system a little to accommodate their specific needs. Eventually, the systems are in danger of non-compliance, or have been drastically compromised.

Another issue to be addressed by this new concept is the idea of auditing not just the Quality Systems, but the Supply Chain. And not just the compliance of the Supply Chain, but the opportunity for criminal activity leading to counterfeiting. The safety of patients around the world depends on this type of assessment, along with a greater understanding of all companies of their role in supply chain oversight.

So the next time you hear about “3rd Party Audits”, be ready to jump into the discussion with both feet: it’s an idea whose time has come.

Tags: Auditing , Compliance , Supply Chain , Quality Systems , Contractor

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