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Institutional Review Boards Contend with FDA, OHRP

May 9, 2011 By Leave a Comment

Patrick Stone, President, TradeStone QA

I have noticed some concern from many IRBs about the GAO & OHRP difference of opinion regarding some aspects of human subject testing. If accreditation is ever fully pulled from an IRB, the reasons will be stated by FDA or OHRP. Through my review of many types of IRBs large and small (central & institutional) I have noted a few trends.

Central IRBs have two fundamental issues to deal with: quality assurance (QA) at the study site, and having a local representative of the community where studies are being conducted present at IRB meetings.

FDA & OHRP are now expecting IRBs to conduct QA audits as is done with most institutional IRBs. If the central IRBs can do a bit more with the funds they receive for service, they will survive this transition. The IRB’s basic functions are to insure patient safety & rights and assure clinical trials are following the CFR (all applicable sections).

In the end, the most basic function of an IRB is patient advocacy & record retention of patient safety discussions (for verification of review). Institutional IRBs in some cases do not scrutinize the in-house clinical trials adequately. In-house clinical trials do not get monitored as frequently due to lack of funds.

The institutional IRB’s should insure the name of the parent company/institution is tied to CFR compliant clinical trials, or the brand may be effected.

But I have a question for IRBs using electronic records: are you ready for the FDA investigator to challenge your 21 CFR Part 11 electronic record compliance? I have observed many large IRB’s staying in the paper records format. Due to cost & physical space issues, electronic is now the obvious way to go.

IRBs are getting more ICH audits and vendor qualifications which help IRBs stay in compliance with ICH guidance and the FDA regulations. FDA needs IRBs in good standing to review the many studies FDA field Investigators will not be able to Inspect. IRB’s play a major part in regulating clinical trials.

When I was with the FDA I always tried to encourage the IRB’s after a 483 was issued to do more for the patients and to effect real change in the amount of studies audited for QA. The FDA cannot get to every study or even thirty percent of the on-going clinical trials combined (biologics, drugs, & devices).

You, IRBs, do the heavy lifting for domestic clinical trial regulatory compliance. Thanks for the hard work.

You can follow Patrick on Twitter here.

 

 

 

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Filed Under: FDA Regulated, Patrick Stone, Regulatory, Warning Letters/Recalls Tagged With: , , , , ,

FDA’s Electronic Record Review Enforcement Policies Present Challenges

April 26, 2011 By 2 Comments

Patrick Stone, President, TradeStone QA

In 1999 the FDA released guidance for industry on the electronic records requirements for human clinical trials involving drugs, devices & biological entities (including the manufacturing of the approved products previously listed). In 2002 the FDA started training the field investigators how to review electronic records during routine inspections of human bioresearch and manufacturing for drugs, devices & biological entities. The catch was FDA investigators were not able to actually cite violations for 21 CFR Part 11 (code of Federal regulations) until approximately 2006.

The FDA instructed field investigators to only write up 21 CFR Part 11 violations if there were other non-Part 11 violations as well. One of the reasons it took so long to enforce the 21 CFR Part 11 violations was that fact that TurboEIR (FDAs report writing template system) did not have 21 CFR Part 11 483 cites. TurboEIR 483 citations became standardized because of the inconsistencies of 483s issued throughout the nation.

Fast forward to 2009 and the FDA starts to ramp up electronic record review for every firm that uses electronic records.

As an FDA investigator I have conducted many electronic record reviews and discussed many 483 cited observations with the Center for Drug Evaluation & Research and the Center for Devices and Radiological Health.

The most recent inspection I conducted for electronic records was a molecular diagnostic laboratory conducting testing for human clinical trials. This was a very special case in which I observed the clinical trial data did not match the data-listing provided by the sponsor. Long story short, the firm was using a data-stick to transfer original data-output and transferring it to an Excel data-set. Microsoft Excel® is not 21 CFR Part 11 compliant and the Excel® program cut off too many digits after the decimal place. The solution was an easy fix in that I suggested the molecular lab simply print out the original data and use that instead of the data-stick transferred data.

The Center put a short hold on the project until the reems of paper could be submitted in proper fashion.

The moral of the story is that as a sponsor or health care manufacturer you have to ensure that any projects slated for all electronic record submissions must be qualified and verified to comply with the electronic record regulation.

I will also give you one more example of a scenario where a project was held up by the agency for electronic record issues. I was inspecting a human clinical drug trial and I observed that source data did not match the sponsor provided data-listing because when the study was closed out and the data-lock was put in place it changed the audit trials and greyed out many data-points.

When choosing an electronic records vendor make sure that the data is never obscured or unreadable when the clinical trial is completed and data-lock is in place. You have to go from cradle to grave with your data and validate every step.

The FDA has made numerous electronic records exemptions for the Department of Defense and other U.S. Government agencies under the following exemption law (device products). A Compilation of Exemptions for Electronic Products Found in 21 CFR Chapter I, Sub-Chapter J — Radiological Health Parts 1000 – 1050.

However, the FDA does not currently abide by the electronic records regulation it enforces, for another case of do what I say, not what I do.

You can follow Patrick on Twitter: http://twitter.com/BIMOQA

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Filed Under: FDA Regulated, Medical Devices, Patrick Stone, Pharma/Biotech, Regulatory, Warning Letters/Recalls Tagged With: , , , , , , ,

What to Expect When the FDA Comes Calling

April 20, 2011 By 1 Comment

Patrick Stone, President, TradeStone QA

Enduring data validation audits and for-cause audits for human clinical trials involving biologicals, devices, or new chemical drugs may at first remind some of going to the dentist to get your wisdom teeth pulled.

But, the FDA has just as much at stake as your company does in the products marketed in the U.S., because if there is a problem or unsafe conditions FDA gets blamed for not doing enough.  That’s top of mind for most inspectors and important for regulated entities to remember.

With that in mind, let’s examine industry trends for these types of inspections.

Lets start by what Consumer Safety Officers (CSOs) look at first.  The regulatory binder is a road map of what happened during the clinical trial.  The IRB approvals, FDA approval documentation, and protocol versions are reviewed and recorded for the report.  The monitor reports and frequency of visits directly corresponds to the amount of observations FDA CSOs finds. So far, so good.

The areas most scrutinized for review are the protocol deviations & violations and adverse event reporting.  If a serious adverse event was not reported or not reported per protocol, you’d better expect a 483.  Failure to follow the IRB approved protocol version is the most cited 483 observation.

How does this keep happening over and over again? Easy: research clinic turn-over, lack of training on updated protocol or study procedures and the lack of monitoring.  The FDA is now requiring 100% consent form review of all subjects.  Failure to obtain informed consent with IRB approved document is the second most cited 483 item.

The third and most documented for clinical research 483 items is lack of complete or inaccurate source documentation.  The FDA is now requesting CSOs to audit the firm electronic systems and record any deficiencies on a 483.  The electronic records evolution started in 1999 and the FDA is now catching up and training CSOs to find your Part 11 computer system shortfalls and deficiencies.  Here, the FDA is turning to the ICH model as a bridge to the European Medicines Agency counterpart inspectorate.

The EMA model requires third party QA for every research trial which has proven to cut down on regulatory deficiencies.  In my opinion having that third set of QA eyes is all the difference between no action indicated (NAI) &  voluntary action indicated (VAI) from official action indicated (OAI) and a project hold.

Editor’s note: This is the the first in a series from our new blogger, Patrick Stone, M.S.  Patrick left the FDA in March 2011 after 12 years as a Biosresearch monitor at the agency’s Austin, TX office. He’s now President of TradeStone QA. While with the FDA, Patrick conducted domestic and international inspections of clinical investigators for pre-approval of pharmaceutical drugs, pharmaceutical drug manufacturing plants and domestic Institutional Review Board investigations.

As Stone recently told us, “I have worked closely with all departments (except foods CFSAN) CDER CBER CDRH and CVM. My work has gone through all of those department heads, too. I have 13 warning letters, one NDA revocation, and countless 483’s. I completed on average of 24 BIMO (clinical trial) audits every year since 2001 when I started conducting audits solo. It is my hope to bring some of that experience to readers of this blog.”

You can follow Patrick on Twitter: http://twitter.com/BIMOQA

 

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Filed Under: FDA Regulated, Patrick Stone, Pharma/Biotech, Warning Letters/Recalls 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: , , , ,

FDA Lifts Curtain on Inspection Process, Rationale

March 25, 2010 By 2 Comments
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Gotta give the FDA some credit here. In addition to its transparency initiative we’ve talk about before, the agency is also trying to remove some of the mystery about how it handles inspections and other inner workings at the FDA. From where I sit, it appears to be a sincere effort and I believe it is helping outsiders better understand what the FDA is trying to do – and how it is trying to do it.

For example, at the second in a new series of monthly online webinars, FDA’s Michael C. Rogers, deputy director, Office of Regional Operations, said today (March 25, 2010)  tried to outline how an FDA inspection tends to work, and what drives inspectors before, during and after an inspection.

As an aside, Rogers also said that the agency currently has about 1,800 total inspectors across its full portfolio, though food gets the bulk of the bodies. He also said there will be more foreign inspections this year, and that the number should continue to grow.

Inspections are based on risk, Rogers said. In other words, the riskier the potential drug, device or food item, the more likely they will be inspected.

Most inspections are unannounced, Rogers said. Before they go on-site, the inspector on inspection team will look at previous inspection reports and identify what corrective actions were promised during prior inspections. They also prepare inspection tool kits with sampling equipment, info to drive inspection based on guidance documents and the Investigation Operations Manual. They also carry a camera to document evidence.

They also conduct “for cause” inspections driven by consumer complaints or other outside activity.

Typically, the inspection begins with a discussion with management to explain the purpose of the inspection, and they try to learn about the corporate structure and any changes made since last inspection. They also ask about complaints, positive tests or returns. Answers to those questions help FDA inspectors focus their on-site efforts.

Next, they go to the physical manufacturing area. They try to observe and understand the on-site process. They ask about acceptance criteria and want specifics on failures, especially the reasons.

Inspectors also draw a diagram of the facility showing the manufacturing process from start to finish. They’re looking for problems in the system and looking to identify critical control points in the manufacturing process.

FDA inspectors then identify procedures in place and assess if company is actually following them. They also look for controls in place to mitigate any contaminated products.

They also look at training and cleaning programs. They also watch employees while they are actually making the product.

If they find evidence of an adulterated product, they collect evidence based on inspector observations and collect samples to prepare their case for possible legal action in court.

At conclusion of inspection, the FDA team meets again with management. They then inform the top company official what is in the official Form 483. That form documents observations during the inspection but does not include final recommendations. They also ask for the firms corrective actions planned or in place to get into compliance.

These corrective actions are taken into account as agency formulates official recommendations.

After the inspection at the firm, the inspector develops a report back at the home office. It includes evidence collected and what the firm has already agreed to do about any shortcomings.

In some cases firms can offer voluntary corrections. But sometimes the agency decides it needs enforcement action such as a warning letter, and can also impose civil and/or monetary penalties.

The webinar was extremely popular. In fact, it “sold out” so many who tried to join it could not get in to the live event. There will be a recording available on Monday March 29.

UPDATE: Slides are now available from this event here in PDF format.

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Filed Under: FDA Regulated, Food, Medical Devices, Michael Causey, Pharma/Biotech, Regulatory, Risk Management, Uncategorized, Warning Letters/Recalls Tagged With: , , , , , , , ,

Part II: Former FDA Inspector Miles | Key to Avoiding More Trouble with the FDA is Identifying Root Cause

March 23, 2010 By 1 Comment

Ken Miles, Former FDA Inspector

Ken Miles, Former FDA Inspector

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 medical device inspections, CAPA, quality systems, audits, training and more.

Q: Where do you think companies fall short when it comes to implementing CAPA systems?

A: Some companies have a great CAPA program that is tied in with metrics, management reviews, etc., but ultimately may be only looking at trend analysis studies of post-production products. Unfortunately, they neglect trends with suppliers and internal production operations, or visa versa.  Valuable data can be obtained for correcting problems in their factory by looking at all trends: suppliers’ and in-house non-conforming materials and components, scrap rates, training issues, complaints, competitors’ non conformances (ie Warning Letter), etc.  Sometimes they’ll discover ”a peak in noncomformance with a certain product line”, but they fail to break it down to reveal that the nonconformance(s) only involve one or two models within the product line which is often the real culprit.

Company managers need to ask themselves, is it one model or all models? A certain shift? A certain part of the plant? Finding the root cause is very important in order to effectively resolve the problem(s). Companies need to isolate the problem and find out if it’s widespread, model specific, or a component. The big picture of using metrics is great, however, if you can’t drill down to the specific problem and root cause, then it’s really not solving the problem.

Q: Can you give us some examples of what you saw as an FDA inspector?

A: One time I was at a large global manufacturer and they had a lot of returned motherboards for ultrasound systems (hundreds of boards returned per month.) Instead of analyzing and finding the root cause of the problem of all these returned boards, they would simply rework and repair them – over and over again. These boards had a very high rate of return, but they would all just go into a big hopper for rework. They should’ve taken the time to do a root cause analysis, but they didn’t, preferring to continue to fix them. None of this was logged into a system, and no failure investigations were ever conducted.  Think of the risk to consumers and to the companies’ reputation and earnings! Think of the enormous waste in time and funds and other resources used for fixing the same problems over and over again.

This firm ended up having a major investigation by the FDA with recalls and monetary fines in the millions of dollars. If they had an effective CAPA system in place with root cause and failure investigations, they could’ve fixed the problem once and for all instead of reworking hundreds of motherboards per month.

Q: Why do you think medical device companies have such a problem with CAPA?

A: The biggest problem I see has to do with a lack of human resources. Typically a person in charge of CAPA has too many tasks and things tend to fall through the cracks. This generally happens to smaller companies with growing pains. That said, it also happens with the biggest ones, too. Bottom-line: the failure is about not devoting enough resources to CAPA, and letting other issues distract them because they are overworked.

Click here to learn more about CAPA Systems.

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

FDA Continues to Affirm Commitment to Swift, Aggressive, and Effective Enforcement

October 20, 2009 By Leave a Comment
Mark Mansour, Partner, Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

In August, Commissioner of Food and Drugs Margaret A. Hamburg, M.D., outlined her commitment “to prevent harm to the American people” through swift, aggressive, and effective enforcement of FDA laws and regulations at a Food and Drug Law Institute (FDLI) meeting. Last week, FDA officials speaking at the FDLI meeting on enforcement reaffirmed that commitment, warning that “past performance is no measure for future performance” and that companies can expect a “flurry of warning letters.”

FDA staffers have indicated that the agency’s ramped up enforcement efforts will include a holistic and collaborative approach between the agency’s centers in such areas as advertisement enforcement; “blitzes” focused on undeclared allergens, label reviews and warehouse inspections; and data quality.

Among these initiatives, the Center for Drug Evaluation and Research (CDER) has indicated that its approach will include paying closer attention to compliance weaknesses and sloppiness as signs that other reporting could also be sloppy, ensuring proper monitoring of scientific research and data for new drug applications, and working with other centers on matching enforcement priorities.

The Division of Drug Marketing, Advertising and Communications (DDMAC) has also stated that it will dedicate more resources to identifying the most serious violations and getting more actions, through paying closer attention to promotions that could wield the greatest negative impact on public health. DDMAC will also be paying close attention to newly approved products, products with significant risks, or products cited in the past or currently subject to a complaint.

More information on the FDA’s increased enforcement efforts is available at here.

See also: Don’t Ignore 483s…it’s in Your Best Interest to Respond in Writing

See also: The Most Common Drug and Device GMP Items

Mark Mansour is a partner in the firm, Bryan Cave, LLP

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Filed Under: FDA Regulated, Mark Mansour, Regulatory, Warning Letters/Recalls Tagged With: , , , , ,

FDA's Hamburg Talks Tough on Inspections, Enforcement, Warning Letters at FDLI Forum

August 10, 2009 By 1 Comment
Mark Mansour of Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

FDA Commissioner Margaret A. Hamburg put industry on notice in a brief but well orchestrated rollout of FDA’s new enforcement policy.  The message, in Dr. Hamburg’s own words, is that “the FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible.”  On the job now for just shy of three months, Commissioner Hamburg addressed a group of industry representatives, attorneys, consumer representatives, and media at an August 6th event sponsored by the Food and Drug Law Institute in Washington, D.C.

Dr. Hamburg expressed concern about what she described as “unreasonable” delays in FDA enforcement actions in the recent past, and said that “serious violations have gone unaddressed for far too long.”  She observed that that the enforcement process is “too long and arduous when the public’s health is in jeopardy.”

Hamburg laid out a series of steps FDA intends to take, presumably starting immediately:

  • Set post-inspection deadlines. The FDA will establish a clear timeline for regulated industry to respond to significant FDA inspection findings, generally giving no more than 15 days to respond to such findings before the agency issues a warning letter or takes other enforcement action.
  • Take responsible steps to speed the warning letter process. The FDA will streamline the warning letter process by limiting review of warning letters by the Office of Chief Counsel to those that present significant legal issues.
  • Work more closely with FDA’s regulatory partners. In some cases, such as with food safety issues, state, local, and international officials can act more quickly than the FDA. When public health is at risk, the agency will coordinate with its regulatory partners to take rapid action.
  • Prioritize follow-up on warning letters and other enforcement actions. The FDA will work quickly to assess and follow up on corrective action taken by industry after a warning letter is issued or major product recall occurs.
  • Be prepared to take immediate action in response to public health risks. To better protect the public health, the agency is prepared to act more quickly and aggressively to deal with significant public health concerns and violations. Such actions may occur before a formal warning letter is issued.

Develop and implement a formal warning letter “close-out” process.  If the agency can determine that a firm has fully corrected violations raised in a warning letter the agency will issue an official “close-out” notice and post this information on the FDA Web site. This will be an important motivator for corrective action by manufacturers.

What Hamburg did not address is what will be done to streamline the approval process for medical devices and for other FDA-regulated products, nor did she address the persistent and growing problem of unqualified inspectors roaming plants armed with the authority to enforce.  No one disputes the need for vigorous, predictable enforcement, but FDA’s credibility is not threatened solely by the perception that it cannot keep the marketplace safe.  It is threatened as much by the reality that for those products that require pre-market approval, there is no end in sight to the delays and the absence of sufficient qualified technical staff to evaluate products and therapies and facilitate their release to the medical and patient community.  Ignoring that problem while focusing on regulating to the worst common denominator of the industry, by any a measure a very small minority, may make great headlines. Unfortunately, it leaves unaddressed some of FDA’s major deficiencies.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

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Filed Under: FDA Regulated, Mark Mansour, Regulatory, Warning Letters/Recalls Tagged With: ,

Don't Ignore 483s…it's in Your Best Interest to Respond in Writing

July 13, 2009 By 7 Comments

fda-logoEven though there’s no regulatory requirement to respond to an FDA 483 inspectional observations report, it’s in your best interest to do so in writing, according to FDA sources. In a recent presentation by Anita Richardson, Associate Director for Policy Office of Compliance & Biologics Quality, she outlined four reasons for submitting a comprehensive 483 response, and eight suggestions for an effective response.

Four reasons for submitting a well-prepared and timely 483 response:

  1. Could possibly mitigate an FDA compliance decision for further action (warning letter, etc.) “As a general rule, a Warning Letter should not be issued if the agency concludes that a firm’s corrective actions are adequate and that the violations that would have supported the letter have been corrected.”
  2. Demonstrates to the FDA (and other stakeholders) an understanding and acknowledgement of the observations
  3. Demonstrates to the FDA (and other stakeholders) a commitment to correct, i.e. the intent to voluntarily comply
  4. Establishes credibility with FDA

Eight suggestions for an effective 483 response

  1. Include a commitment/statement from senior leadership
  2. Address each observation separately
  3. Note whether you agree or disagree with the observation
  4. Provide corrective action accomplished and/or planned; tell FDA the plan
    • Be specific (e.g. observation-by-observation)
    • Be complete
    • Be realistic
    • Be able to deliver what you promise
    • Address affected products
  5. Provide time frames for correction
  6. Provide method of verification and/or monitoring for corrections
  7. Consider submitting documentation of corrections where reasonable & feasible
  8. BE TIMELY

Good advice. And remember…

“A well-reasoned, complete, and timely 483 response is in your best interest.”

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Filed Under: FDA Regulated, Regulatory, Tamar June, Warning Letters/Recalls Tagged With: , ,