May 25, 2013

Posts Comments

You are here: Home / Archives for Regulatory Compliance

Part II: Next Practices for Selecting an Enterprise Quality System

February 12, 2013 by Leave a Comment
John Moroney of AssurX, Inc.

John Moroney, VP, Sales, AssurX, Inc.

Note: In part one, we looked at how to approach the selection process, assess vendor capabilities, and find the right philosophical “match” for your particular organization. In part two, we’ll take you through next practices for scoring vendors, conducting an effective vendor search, and clearly defining project scope and costs.

Beware of how to measure. Companies frequently will devote significant effort and elaborate scoring methods to grade vendor functions resulting in very precise but ultimately irrelevant scores. Academic studies of software project success indicate that product functionality contributes less to success than the customer and vendor implementation team and process.  Keep the assessments simple and double check major variances with the team members and the vendor.

One approach to avoid feature/function obsession is to develop scenarios for vendors to demonstrate. Select one to three primary areas of business improvement (CAPA, Customer Complaints, etc), develop an outline of how the team would like these processes to be and review the outline with key vendors. This may result in a more detailed scenario for each vendor to demonstrate, or simply request the vendors to show how they would support the original description.

Once the team has narrowed down to the final one or two vendors, it is advisable to speak with customers, but first consider what questions you would like to have answered. This will achieve at least three things:

  • Focus the team on the primary concerns with the vendor/product/project.
  • Assure that the reference company is appropriate.
  • Allow the reference company to have the correct person available.
  • Not miss any key points during the meeting.

This can be an excellent time to hear the lessons learned by the customer – not just about the product or vendor but the project itself and how it has evolved over time.

Quality WhiteboardDefined Project Plan and Costs

At this point the team should have firm costs and establish (possibly with the vendor’s help) a project timeline. If it has not been done already, a business case justifying the project is frequently required to secure executive approval.

The most common source of frustration and delay at this stage is the team not knowing the internal process for getting the project approved. In many companies a capital request and presentation is required. Contracts and agreements usually must be reviewed and/or modified requiring procurement and possibly legal resources. Vendor setup and approvals and possibly background checks may also need to be done. Depending on the company, a separate plan to work through this stage is sometimes helpful.

Often your project is vying with other capital needs for funding. Furthermore, few members of the capital committee or approval executives will know much about your project. It can be useful to create a summary presentation describing the business need for this software, the vendor selection process, general project plan, the benefits and when they will begin to accrue. Include the alternatives as well and the recommendation and consider framing the presentation to address these questions:

  1. Why do anything?
  2.  Why do it now?
  3. Why this recommendation/alternative?
  4. What does the company need to invest – not just money but what resources?

Closing

Embarking on the implementation of a new EQMS is much like any project where change is necessary. Success will hinge on consistent effort and working through obstacles and resource limitations as well as resistance to doing things differently.

Here are some final tips to help ensure success:

  • Secure solid management support – make sure the project leader has been given the time, the resources and organizational support necessary.
  • Get requirements defined, agreed upon and documented – reference and revise frequently.
  • Avoid the geek factor –  beware of flash. Remember, features can often be added later.
  • Don’t let perfection be the enemy of the good – a version 2.0 can come later.
  • Strong team and communication – better to get issues out early.
  • Focus on small wins, quickly – iterate, test and refine along the way.
TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: Quality Management, Regulatory, Risk Management Tagged With: , , ,

Study: FDA Enforcement Growing for Medical Device Companies

February 11, 2013 by 1 Comment
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Turns out that some paranoid people have a reason to, well, be paranoid.

Researchers from the London Business School issued a report last year finding that many people at work who thought they were being talked about were probably right.

Maybe some in the medical device industry can be forgiven for thinking the FDA has come down harder on them in recent years.  A new study kind of backs their “paranoia,” too.

FDA efforts since 2009 to strengthen key policies has resulted in more medical device enforcement that will have a “long-lasting” effect on the industry, says an independent study from Greenleaf Health’s enforcement and compliance team. It was overseen by former FDA Associate Commissioner for Regulatory Affairs, Michael Chappell.

The Medical Device Enforcement Report focused on four specific area of medical device enforcement data: FDA inspections, 483s, warning letters and product recalls.

Medical Device Recalls

There is a general correlation between CDRH and FDA increasing recall numbers. In 2007, 1,279 medical device products were recalled – that number soared to 3,211 in 2011.

Here’s are some of the more telling stats:

  • Since 2005, CDRH inspections have accounted for 10 – 12% of all FDA inspections.
  • CDRH inspection numbers have increased at a rate consistent with FDA inspection numbers, the report sats. In 2005, CDRH inspected 2,304 facilities compared to 3,369 in 2011.
  • In 2008, CDRH issued 152 warning letters, compared to 200 in 2010.
  • In 2007, 1,279 medical device products were recalled – that number soared to 3,211 in 2011, according to data collected by Greenleaf.
  • Over the last five years, 483s issued to device manufacturers have accounted for 6% of all 483. The number of 483s issued by FDA – for all regulated products – has increased from less than 4,000 in 2008, to nearly 5,000 issued in 2010. The number of 483s issued for CDRH regulated products has remained steady over the 5-year period annually.

Greenleaf’s team suggests that these rising numbers can be attributed to a conscious FDA policy shift that includes more efficient review of warning letters, increased prosecution of misdemeanors, creation of the “Bad Ad” program, and the increased role and responsibility of FDA enforcement officials.

Here’s the $64,000 question: If you are paranoid that something bad is happening to you, and then you learn you may be right and not paranoid, is that a relief?

We’ll let those in the medical device industry speak for themselves on that one.

To purchase the full study, go to www.greenleafhealthllc.com

 

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: Bloggers, FDA Regulated, Medical Devices, Michael Causey, Quality Management, Regulatory, Warning Letters/Recalls Tagged With: , , , , ,

New Year Doesn’t Change FDA ‘Old’ 483 Focus

February 6, 2013 by Leave a Comment
Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Looks like the FDA missed the memo that it’s a new year. If recent 483s are any indicator, the agency hasn’t made any serious New Year’s resolutions about changing its enforcement focus.

In fact, we could turn to two ancient FDA beat reporters, William Shakespeare and WIlliam Faulkner, to perhaps best sum up the most effective way to predict the FDA’s enforcement strategy in 2013.

In The Tempest, Shakespeare tells us, “What’s past is prologue.”

Or you could go with Faulkner in Requiem for a Nun with its famous observation, “The past is never dead. It’s not even past.”

You could also skip the literary quotes and take a look at a recent crop of 483s yourself.

If you fancy yourself a speed reader, you might save time with a quick skim and quickly get the flavor of FDA’s top offenders, if you will. You’ll see the same terms and key words come up over and over in FDA 483s of late:

 

  • Procedures for receiving, reviewing and evaluating complaints not adequately established
  • Procedures for quality audits have not been adequately established
  • Procedures not established for quality audits.

warning640If you’ve got a bit more time, we think it’s worth it spending some of it taking a closer look at the agency’s most recent enforcement actions. In fact, an examination of a single month, October 2012, gives us many clues about where FDA inspectors are looking when they come calling.

In late October 2012, the agency hit D.E. Hokanson Inc.,  a vascular diagnostic product maker based in Bothell, WA, with observations the company had not adequately put procedures in place to review, receive and evaluate complaints by a formally designated unit.

Earlier that month, the FDA hit SRI Surgical, a medical device specifications developer in Maitland, FL, for failure to adequately establish CAPA procedures.

A day earlier, Malem Medical, a device manufacturer based in the UK with  offices in Maryland, was observed to have not adequately established procedures for quality audits — or adequately trained personnel.

On October 1 last year, the FDA hit Danmar Products, a device manufacturer in Detroit, also for not having established quality audit procedures — or adequately trained personnel.

It’s worth noting that each of these 483s came from a different FDA Inspector. In other words, this focus is wider than a single Inspector with a pet peeve.

The release of 483s lags a few months, so it is possible that the next crop of FDA 483s will show a radically different focus from FDA inspectors.

But don’t count on it. Neither William would.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: Bloggers, FDA Regulated, Medical Devices, Michael Causey, Quality Management, Regulatory Tagged With: , , ,

Part I: Next Practices for Selecting an Enterprise Quality Management System

January 31, 2013 by Leave a Comment
John Moroney of AssurX, Inc.

John Moroney, VP, Sales, AssurX, Inc.

Editor’s Note: In this two-part series, you’ll learn the most effective ways to select an Enterprise Quality Management system, why it’s a critical long-term decision, and common pitfalls to avoid.

First, let’s simplify things a bit: Selecting an Enterprise Quality Management system is no different than any other major business purchase decision. Broadly speaking, that means you’ll face similar issues and risks you’ve encountered before.

So, if you’ve already got experience making big purchases, you should begin the process with a relatively high degree of comfort.

Unfortunately, most companies do not make major purchase decisions very often, whether buying an enterprise software system, purchasing or leasing a new facility or committing to a major piece of capital equipment. These decisions have long lasting effects and can be career enhancing or threatening for those involved.

With that in mind, let’s examine some proven ways to improve your selection process.

Having a plan is usually the best approach, but what should the plan include? Experience shows the best have several stages:

  • Defining requirements & project objectives
  • Initial investigation of options
  • Detailed vendor reviews (not just product!)
  • Defined project plan & costs
  • Corporate approval and kickoff

quality circleConsider that this process will likely take several months, so one of the first steps is to set expectations within your organization. Explain to colleagues and superiors that this is like a major remodeling project. It has many steps, will require time and effort, and you only want to do this once, correctly.

Defining requirements & project objectives

It is surprising how few companies spend enough time defining the objectives and success metrics a new EQMs should deliver.

Start with the key business issues you want to address. For example:

  • Is there an inability to understand the root cause of product failures? How big is the problem – quantity, dollar impact, lost customers, etc. Who in the company is affected? What are the KPIs (Key Performance Indicators), and what values would be considered excellent? How difficult is it to collect that information?
  • What is the cost of supplier quality and how can that be reduced or charged back? Who are the best suppliers and the worst? What do they cost the company per year?
  • Is it difficult or impossible to determine how many complaints are received by a customer? What were the reasons for those complaints? How many were resolved and how long did it take? Who would like to have that information, and what is it worth to the company?

Performing this exercise yields three outcomes:

  • What constitutes success for this project?
  • What are the potential financial benefits of the project and agreement on what the project investment should be (the budget)?
  • What product/vendor capabilities are required to support the outcomes?

Although this stage of the project may be done by an individual, the creation of requirements should be based on interviewing all of the key stakeholders including users, managers and executives. A project selection team should also be recruited from these ranks and most often should include IT professionals as well.

Initial investigation of options

With so many options available, how can the team be sure to include the best choices? First, understand what the corporate ERP system vendor can deliver. Often this will be both the least expensive and the easiest to deploy, and at the very least should be evaluated to provide a base line to compare against other best of breed choices.

Some companies have a strict policy that no third party applications will be purchased unless a strong business case for not using the ERP vendor’s modules is first made. In larger companies, other divisions or business units may have already implemented an EQMS. Not only is there much to gain by interviewing those users, there may be corporate edicts or at least preferential pricing and implementation resources already available for deploying that product.

Other choices can be found through web searches, trade shows, etc. but one of the best approaches is to network with industry colleagues. Not only will you benefit from their experience, but to the extent their vendors have a focus upon your industry, best practices will be available to your team. Frequently, customers will have suggestions and possibly preferences for what system to select or at least a short list of what their other suppliers use.

Certainly one criteria at this point is cost, but another is whether to purchase the software or subscribe to a hosted solution. Some vendors offer both forms, but many do not, so part of the initial criteria needs to be settled with the IT organization and corporate policy.

Most companies will want to consider vendors with customer profiles similar to themselves, whether by size, industry, technology, etc. and/or a strong user group. For example, life science, aerospace and automotive companies have specific needs which will narrow the field of suitable vendors. It is important to engage the IT organization because there may be preferences for certain technology platforms such as Oracle versus Microsoft databases or integration to specific ERP systems.

How many vendors should be evaluated? It is difficult for a team to devote time searching for a vendor selection and “fitting in” their normal work; therefore most companies might interview six to ten vendors but whittle that down to three or five vendors for the next phase of detailed vendor reviews

Detailed vendor reviews

Now that your team has created a short list, it makes sense to take a deeper dive. Much of the focus at this stage should be the product functionality, and maybe “look and feel”. It is critical to establish criteria at this stage, as a “pretty” product may not be the best product available for your company. In the software industry a term frequently used is the “whole” product – not just the software. That would include, beside software functionality, elements such as:

  • Support – uptime performance metrics, Level One support issue and response times, what is the support process and what are the metrics?
  • User community – is there one, how active, who participates, is it vendor or customer driven?
  • Industry domain knowledge – does the vendor know your industry and have support staff with experience. Does the vendor know how to work with companies your size and scope?
  • Product reliability – how often do customers have problems, how severe are they?
  • Implementation track record – how often do customers fail to implement? Why? Is there an implementation process?
  • Vision and direction – is the vendor commited to being an EQMS, do they have a product plan and does their product and market strategy align with your company’s plans?
  • Customers – who are they and do they align with your kind of company? Are they highly dependent on the vendor or can they support themselves?
  • Total cost – beyond the initial project, what costs could there be in the future? Additional users, modules and/or changes? Is there a cost for future versions? What cost protections will the vendor provide? What are customer experiences?

Leading vendors understand the elements of the decision process and will be forthcoming with information. Successful sales people, who have participated in dozens if not hundreds of selection cycles, have a deep understanding of your industry’s best practices and the options in the market – usually much better than consultants or program managers who may lead selection projects only a few times per year.

Note: In part two, we’ll look at the most effective ways to “score” vendors, narrow the search process, and define project costs and scope.

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: Quality Management, Regulatory, Risk Management, SaaS & Cloud Computing Tagged With: , , , ,

Employees Must Wash Hands

January 23, 2013 by 1 Comment
Kim Egan

Kim Egan, Founder, Saltbox Consulting

On January 4 2013, FDA took the first step in its history to regulate produce farmers. The agency issued a 547-page proposed rule that spends a lot of time reducing everything humanity has learned about plants since agriculture emerged in the Fertile Crescent 10,000 years ago in to U.S. Government jargon.

It is interesting reading if you like that sort of thing. There is an entire section devoted to the hazards of sprouts and another to the taxonomic and agricultural definition of mushrooms. FDA takes no position on glass or metal fragments in soil, but the “hazards unique to cilantro” warrant mention. We are introduced to an excellent new phrase: “pre-consumer vegetative waste.”

There are some stupid new acronyms, like Raw Agricultural Commodity (RAC) and some blindingly obvious regulatory findings, such as: “The statutes we describe above, and previous interpretations of the concepts of RACs and processed food as set forth in the 1998 Joint EPA/FDA Policy Interpretation and the Antimicrobial Guidance, lead FDA to tentatively conclude that the basic purpose of farms is to produce RACs and that RACs are the essential products of farms.” (Translation: Farms grow produce and produce is what farms grow.)

farmThere are also a lot of exemptions, such as food grown for your own use and food that is not normally consumed raw. This means that FDA’s first ever effort to regulate farmers does not apply to asparagus, corn, eggplants, figs, lentils, peanuts, or potatoes, among many others. Figs? Why not figs? Fresh black mission figs on a cracker with brie are yum…

To spare you the agony of reading the whole thing, I have boiled the whole 547-page proposal down a few key points. If you are a farmer:

  • Wash your hands.
  • Clean your equipment.
  • Send sick employees home (this means infectious diseases as well as suppurating wounds).
  • Change your clothes if you just spent a bunch of time shoveling manure.
  • Don’t put portable toilets smack in the middle of your irrigation source.
  • Don’t dump raw sewage on your fields.
  • Don’t let dead wildlife decompose in your fields.
  • Don’t harvest rotten apples.
  • Don’t bother with Purell; it doesn’t work on actual clods of dirt or manure.

Were I Queen, I would add:

  • Wash your produce before you eat it.
  • Know where your produce comes from, and don’t eat it if it came from a sewer or a nuclear power plant.
  • Follow the “Diplomats Rule” when traveling, i.e.,:
    • things with rinds or husks (oranges, nuts) are usually safe
    • things filled with water (lettuce, tomatoes and cucumbers) less so,
    • eventually you will acclimate, and
    • alcohol cures all.

But this is in fact a serious topic and I think the Food Safety Modernization Act misses the point. FDA really can’t do this by itself and the produce farmer is not the problem. If we want to improve the safety of our food supply, we need to:

  • Figure out a way to keep pharmaceuticals out of the water supply. If they aren’t in the water supply to begin with, they won’t end up in our lettuce and cucumbers.
  • Figure out a way to reduce our over-reliance on antibiotics. We would be less susceptible to food-borne illnesses in the first place if we didn’t routinely carpet bomb the flora in our bodies that keeps us healthy.
  • Figure out a way to prevent surface water run-off. I propose building codes that require green roofs for all new commercial structures over a certain size, and that require green verges on all new roads, etc.
  • Apply existing tort law to food producers who negligently or intentionally put a dangerous food product (raw or otherwise) into inter-state commerce. For biotech crops and hybrid seeds, this could include design defect and manufacturing defect claims, which can carry substantial financial penalties.
  • Take serious steps to increase agricultural biodiversity, which would include ending or seriously reducing subsidies for corn, wheat and sugar, and encouraging effective crop rotation.
  • Solve the problem of migrant farm labor. We depend on undocumented workers to harvest our crops because it turns out that picking tomatoes it not really “unskilled labor,” as the recent example of Alabama shows.

In the meantime, let’s keep things in perspective. A little dirt never hurt anyone.

Kim Egan is the Founder of Saltbox Consulting, a firm that provides legal and compliance advice to entities regulated by FDA and USDA.  She can be reached at kim.egan@saltboxlaw.com and on Twitter at @saltboxlaw.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: Bloggers, FDA Regulated, Food, Kimberly Egan, Regulatory, Risk Management Tagged With: , , , , , ,

Utility Industry Grapples with Larger NERC Enforcement Penalties

January 22, 2013 by Leave a Comment
Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

As we approach the sixth year of mandatory compliance with the NERC Standards, we can see that NERC and the Regions are becoming more experienced dealing with the audit findings and penalties.  As shown in the last two releases of NERC enforcement actions, the non-compliance fines are larger and larger.  We have seen some penalties well over $500,000 (see $725,000 and $950,000 fines, too.)

Some registered entities are leading by example, with strong compliance programs and engagement with industry.  Registered entities are sharing experiences with each other in forums and workshops. They’re talking about their experience with Electric Reliability compliance software, and hiring consultants for independent reviews.  A few companies have even implemented the needed internal corrective action programs (CAPA) that benefit their Find, Fix, Track and Report (FFT) initiatives.

That’s the good news!

The relative bad news is that registered entities are still out there trying to doing the absolute minimum for NERC compliance.  There are reasons for this including a tough economy and over-worked resources.  Registered Entities that have tried to maintain compliance with limited resources and managing through many spreadsheets, weak document control, and lack of proper compliance participation in the industry.  We are still seeing common mistakes out there that can be easily corrected.  As the top Electric Reliability software provider, we see best practices that can anticipate or correct these problems.  Our customers are sharing their success with other companies.  Some of those successes include:

Registered Entities need to take a look at best practices, talk to their industry counterparts and evaluate their programs. They also need to look at strong compliance software tools, remove burdensome internal processes, and build a reliability culture that will be engaged, proactive and identify issues before they become signification violations.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: Bloggers, Electric Reliability, Featured, Regulatory, Risk Management, Trey Kirkpatrick Tagged With: , , , ,

FDA to Medical Device Submitters Using WebTrader: Remove Your Files Now

January 17, 2013 by Leave a Comment
Tamar June, VP, Strategic Marketing, Product Manager - eMDR

Tamar June, VP, Strategic Marketing, Product Manager – eMDR

A January 11, 2013 email sent by Michael Fauntleroy, Program Manager, FDA ESG, is warning those using the WebTrader for electronic submissions to delete their inboxes, or risk losing all documents contained within them in the future. WebTrader is a supposed to be a low-volume submission tool, however, some companies have apparently been using the system as a file server or archival system.

FDA states that the misuse of the system has resulted in significantly lower performance for all other account holders. They suggest removing the submission records and storing it either locally or on a company-wide network. The email also listed the number of “offending” accounts:

1 account has more than 3000 documents
9 accounts have more than 2000 documents
34 accounts have more than 1000 documents
96 accounts have more than 500 documents
763 accounts have more than 100 documents
2833 accounts have more than 20 documents

(Each submission transmission has 3 – 4 documents associated with it. e.g. 20 documents in an Inbox  translates to 5 -6 submissions).

According to FDA, “…ESG’s WebTrader functionality is provided to the industry by FDA as a low cost alternative to send submissions to FDA. The WebTrader Inbox provides the users a view of submissions sent to FDA and receipts and Acknowledgements received from FDA. This inbox should not be used as a storage place for your Receipts and Acknowledgements – once you receive Receipts and Acknowledgements for your submissions you should;

  • Download Receipts and Acknowledgements and save them to your local machine
  • Delete records from your WebTrader Inbox

Following these steps will ensure faster display of the Inbox for you, other ESG users and increase overall performance of the system.”

The email also states “The account owners that have more than 2,000 documents in their WebTrader Inboxes will be receiving an email with a zip file of their messages.  We will delete these documents from your Web Trader Inbox at the FDA immediately. This policy is being re-implemented on a permanent basis.”

In the closing paragraph of the email, written in red ink, the FDA sternly warns: “On February 1, 2013 we will start deleting documents in Web Trader account Inboxes without notice.  Any Web Trader Inbox with more than 20 documents in it will be cleaned starting February 1, 2013. Once the Inbox is cleared of documents (Receipts and Acknowledgements) they cannot be retrieved so WE STRONGLY ADVISE YOU TO DOWNLOAD RECEIPTS AND ACKNOWLEDGEMENTS FROM YOUR INBOX after each transmission.”

Clearly, those who have hundreds or thousands of documents should probably consider upgrading to another type of eMDR submission system.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: eMDR Updates, FDA Regulated, Medical Devices, Regulatory, Tamar June Tagged With: , , , , ,

Drug Labels: Free Speech Yes, Dangerous Speech No

December 19, 2012 by Leave a Comment
Patrick Stone

Patrick Stone, President, TradeStoneQA

The U.S. Court of Appeals for the Second Circuit just overturned the conviction of a drug sales representative promoting off label use for a narcolepsy drug that included fibromyalgia, restless leg syndrome and insomnia (use for drug not approved by FDA). The Dec 3 court decision determined that this falls within the realm of free speech and should be protected. So, they overturned the sales reps 2008 conviction of introducing a misbranded drug into the market.

So is it really just about free speech?

Many off label uses for drugs may be similar in nature to the varying disease states. But the indications above could not be more far apart. Narcolepsy is a debilitating nervous system disease where you fall asleep uncontrollably. Insomnia is a state where you can not fall asleep at all.

Free speech should not harm your fellow citizens. That’s just dangerous speech. I don’t think the Constitution intended to encourage that.

Patients may be harmed by off label use of a drug that has not been clinically proven for that specific disease state. The drug companies are making hefty profits to cover more clinical trials to prove more uses for their medical health products. Off label use does may not always capture SAEs related to off label use. The new SAE’s encountered may not be included for addition to product labeling nor does it prove the off label treatment is effective for the “new use”.

Free speech is not free when the consumer purchases a prescription and is then injured by that drug. Far from free, the patient pays a big cost.

It is very difficult for the average patient to prove a specific drug caused them harm unless they are under a clinical trial where blood and urine samples are drawn regularly to keep track of their health.

I am certainly not against new safe and effective treatments, I am against snake oil salesmen touting panacea “cure all” drugs when in reality no such thing exists.

The False Claims Act for off label drug promotion is a very specific statute. It’s there to keep our medical health product manufacturers and innovators honest.

But false claims aren’t the only law being broken by some offenders. These other offenses include: Physician payout for prescriptions, suppressing risk of the treatment, fictitious clinical trials and price fixing.

There are many more schemes involved and here is a link alerting us to many recent false claims payouts that may break the half a trillion mark.

The FDA will appeal the recent court decision, and this may go to the U.S. Supreme Court for final disposition. But the question remains, will we go back to the snake oil salesman of yesteryear or move forward with transparent, safe and effective health care treatments?

Let’s remember why the FDA was formed over a hundred years ago. It’s about protecting the public health. Not about protecting dangerous speech.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: Bloggers, FDA Regulated, Patrick Stone, Pharma/Biotech, Regulatory Tagged With: , , ,

It’s Time for FDA, States to Step Forward for Public Health

December 5, 2012 by Leave a Comment

Patrick Stone, President, TradeStone QA

It’s clear that the FDA should have more compounding pharmacy oversight, but how long will it take them to make other important decisions on public health?

The recent news is troubling.

Example: According to state and federal records, it took FDA approximately 684 days to issue a warning letter that may have saved lives and time. Usually it should only take 90 days for compliance branch local district directors to decide on a firm’s regulatory outcome. The FDA mandates strict 483 fifteen day response letter times and should also be held to a 60 or 90 day turnaround.

As a former FDA inspector, I’ve been there. Some of the cases I was involved with took 24 months to get a final warning letter decision. This is unacceptable because there is a 6 month follow up that should be conducted.

But if regulators give the regulated industry time to make more  lethal products who is to blame? Usually FDA gets local state authorities involved for immediate detention and embargo of harmful products. Each state has unique authority over products made within it’s borders if they are held for interstate trade. The New England region was also involved with the FDA inspections. The state could have stopped many products from interstate trade before the situation escalated.

PharmaceuticalsThe FDA’s initial inspection on this product began in September 2004 and ended on January 19, 2005. In the Dallas district an Investigator would be reprimanded for taking five months on an inspection. It does not take that long to conduct a compound pharmacy inspection or to collect product samples. It usually takes two or maybe three weeks for this type of inspection. Each district has time limits that can be spent on any one assignment. There seems to be a pattern of errors here that could have prevented lives from being lost with much time wasted.

Going forward FDA must adhere to internal timelines for all inspections and final regulatory compliance determinations. State Pharmacy Boards should allow FDA inspections of firms that compound sterile drug products for conformance with U.S. Pharmacopeia (USP) chapter <797> “Pharmaceutical Compounding – Sterile Preparations,” or cGMP’s. Compound pharmacies should partner with FDA in order to insure safe market distribution of approved drugs.

This should not be a regulatory turf war – it’s a matter of public safety. The state should be brought in early and if necessary take immediate detention and hold actions.  This is a tragic learning experience that should be reviewed with rapid corrective action implementation.

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

 

 

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: Bloggers, FDA Regulated, Patrick Stone, Pharma/Biotech, Quality Management, Regulatory Tagged With: , , , , ,

The Only Vote That Counts: FDA 483 Round-Up

November 6, 2012 by Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Pollsters, prognosticators and pundits love to obsess over the polls before Election Day. Their self-appointed task is sifting for nuggets that will tell us who will win before anyone has actually cast a ballot. But as wide political sages like to say, “The only poll that matters is the one on the day people actually vote.”

Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings.  But the FDAs real “votes” are in the 483s they issue.

Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training.

A letter issued after a month-long inspection that ended in May 2012, cited Cardiva Medical in Alameda, California for failing to adequately train its workers. Its Cardiva Catalyst is “designed to increase the comfort of the manual compression process and facilitate the body’s healing process,” according to the company’s website. It also allegedly failed to identify future training needs for its personnel, the 483 said..

voteDevice manufactuer Coviden in Chicago was chastised after an inspection earlier in the year for CAPA shortcomings lacking “quality data sources that indicate the occurrence of high risk non-conformities.” The firm was also found wanting for failure to have a CAPA in place to “ensure that failure investigations are comprehensive.” Further, the FDA says it found a lack of a CAPA to “correct and prevent the issue of incomplete device history records.”  Coviden manufactuers a number of products, including respiratory monitors and endomechanical products.

Other CAPA-related problems were found at Denver-based Sandhill Scientific. There, the FDA alleges the company lacked adequate an adequate CAPA program to address nonconformities and root causes. The company manufactures monitors aiding in acid reflux detection and a high resolution manometry system.

Arrow International in Parsippany, New Jersey, a Class II manufacturer of catheters,  was hit with a 483 because “a validated process was not reviewed and evaluated when changes or process derivations occurred.”

We’ll keep tallying FDA’s real “votes” and an eye on real trends coming from the agency.

TwitterFacebookGoogle+LinkedInEmailPrintFriendlyShare
Filed Under: Bloggers, FDA Regulated, Medical Devices, Michael Causey, Quality Management, Regulatory Tagged With: , , , , ,
«Older Posts
Newer Posts»