3 Outsourcing ROFs recalled every sterile product with expiration

Dear Readers,

It’s been a long, long time since I gave you any meaningful report on the happenings on the FDA webpages.  Allow me to make two excuses:

1. I’ve been slammed for time with increased travel and because of the publication of the USP Compounding Chapters on June 1.  The inexcusable overreach and rigid dogma of the USP Compounding Committee and the important edits to the proposed language have caused my usual phone call minutes to increase by more than double since then.
2. A second reason I haven’t reported on updates to FOIA or CIRoA lately is that FDA has not been posting updates to either webpage at their customary pace.

Why has FDA’s reporting slowed?  It seems apparent to me that the Agency’s I.T. arm accidentally “broke” FDA.gov.  Relative to my own browsing needs, there are as many dead hyperlinks on FDA.gov as live ones since their website “improvements” in the April-May timeframe.  It’s like the line from a Jim Croce song, “It’s like a jigsaw puzzle with a couple of pieces gone.”

The latest posting on FOIA is STILL the SBoP Referral Letter to WellRx LLC (DBA Home Rx LLC) and you might remember that I covered that action in my APRIL 18 newsletter.  Keep in mind FOIA is not just for compounding actions, it’s for every document that is frequently requested and in high demand from the ORA Reading Room from any stakeholders, so it’s not just compounding people in the dark.  (NOTE – Just as I was preparing to press “Send” on this newsletter, I checked FOIA one last time.  I found a brand new posting made today.  I grunted and clicked on the hyperlink and – VOILA!  It is another “blind” hyperlink that leads to nowhere.)

What we can infer is there are a LOT of FDA pharmacy actions going on, because we’re all talking with our colleagues who recently had them – or STILL have inspectors in.  It’s just that we’re not being informed of it in the usual way.  The hopeful news is that FDA DID post:

• THREE Outsourcing Facility recall alerts;
• Not ONE, but TWO sets of updates to ROFs in June (June 7 and June 19);
• A Compounding Risk Alert on June 7
• Two copious sets of edits to CIRoA on May 19 and another on June 27.

I’ll start by covering the three ROFs Recalls.  There is another recall-related action underway, but I’m not going to address it yet because there is more to unfold and I feel a duty of silence to the entity.  If you want to know more right now, do a Google search because it’s there for you to find.

Apologies in advance that this is going to be a very long e-mail and I hope to follow this one ASAP with another long one.

RECALLS
All three recalls were for, “failure to maintain sterility assurance.”  They were:

• Premier Pharmacy Labs Inc – Recall all Unexpired Drug Product Lots – 6/18/2019
• RXQ Compounding LLC – Recall of All Sterile Products within Expiry and Voluntary Cessation of Production – 6/18/2019
• Infusion Options Inc – Recall of All Lots of All Sterile Products

This is a good opportunity to talk about the process and features of performing a recall.  The 503Bs have become painfully familiar with recalls, but, blessedly, most 503As are uninitiated and unlikely to have had the benefit of learning about recalls from their peers by word-of-mouth.  Recalls are devastating in both time and money to any organization (except apparently Hospira).  Here are some highlights of why that is:

• Your company name will get lots of headlines, but not in a good way.  Even though, you’re bleeding money from the recall, it might still be worth it to retain a professional organization that has managed plenty of them in the past.  I attended a compounders’ conference where David Ball of the Ball Group talked about his services and you might consider keeping his contact information handy. (there’s a hyperlink to his website in the bottom section of this newsletter);
• Your customers are left scrambling and recalls create heartburn for THEM TOO.  You must get the unused, unexpired drug forms back from them at your expense.  It’s a quadruple-whammy – you paid to ship it out, you pay to ship it back, you refund the purchasers’ money, and you pay a small fortune to destroy it.  Ouch, ouch, ouch, and ouch!
• You won’t be producing again until you remediate the issue(s), but you won’t be able to focus entirely on remediation because your phone will be ringing off the hook and your electronic inboxes will be blowing up.  Your happy, patient, cheerful, customers/former customers need explicit instructions regarding HOW to send your now-useless products back and HOW to get their refunds.  This will be a near full-time job for somebody for days or even weeks;
• You need a process and the open, dedicated square footage to receive and store the returns and hold them in quarantine until you and the regulators are done with them. Recognize that it’s vital to have a workable system for keeping these returns grouped, sorted, and efficiently retrievable for testing and follow-up;
• You’ll be paying your entire staff for days or weeks even though they’re not producing any product or revenue, but you can’t afford to lay them off either or face massive “brain-drain.”  Laid-off workers tend to find new jobs as fast as they possibly can;
• If you don’t have a well-considered SOP ready when a recall occurs, well – I don’t even want to think about it.  Every bullet point above needs to be completely covered in your RECALLS SOP, but these bullets are far short of a complete listing.  The best drug recall is the one that never happens and the best way to avoid a recall is a robust and effective Quality Unit.  Keep in mind that a competent Quality Unit can likely limit the scope of a recall.  Instead of recalling everything within expiry, you might only need to recall a few SKUs.  Still painful, but probably less lethal to your future prospects.

CRAs

• FDA issues a CRA outlining its concerns regarding the use of dietary grade glutathione to compound sterile injectables.  

ROFs

We got TWO updates to ROFs in June – not just one:

6/15/2019:

• BMD SKINCARE INC of Canoga, CA VANISHED from the List.  I have no idea why they’re gone, so If you do, please inform me.
• Advanced Pharmaceutical Technology, Inc. of Elmsford, NY makes its first-ever appearance on the ROFs list.  The ROFs webpage tells us they registered on January 1, 2019 and that they intend to compound from Bulk API.  Their contact person is Marco Persichillo at 914-358-5260.
• Apollo Care of Columbia, MO (a 503B ROF) received a Warning Letter on 3/20/2019.
• CAPS-Phoenix – I tip my cap to my friends at CAPS for taking their massive new Outsourcing Facility through its initial FDA inspection WITHOUT RECEIVING A 483!  This is only the third successful “first inspection” for a 503B. 
  • I had the opportunity during my talk at the CBI Conference in Silver Spring on 6/20 to call on four 503B individuals to stand up and be recognized for having withstood FDA inspections without receiving a 483.  They were:
    • Kristopher Le, who is now with his own firm (Amicus Consulting), but in 2016, led Nephron through its initial inspection with no 483 – a first!
    • Robert Nickell, CEO of Nubratori, who was only the second to accomplish the feat.  (Robert wasn’t in the room when I was speaking but I did see him in Silver Spring that week.)
    • Mike Koch, the operations leader for the CAPS team that just brought in the clean inspection for Phoenix.
    • Pat Stephens had a rockier early experience with FDA, but she showed us all that recovery is possible.  She led Medi-Fare through TWO CONSECUTIVE 483-FREE inspections, which is the only company to achieve that as far as I know.
  • There are a lot of armchair experts out there purporting to teach you what you need to know about FDA success, but my own thought is if it were my money on the line, I prefer someone like Kris or Pat, who have been there and done that.  (I believe Robert and Mike are otherwise occupied and unavailable).  My first question to any consultant would be, “How many 483-free FDA inspections have YOU led?”
  • I feel sure that all four of these actual experts would tell you that it takes a skilled, seasoned team and they didn’t do it alone, but with able leadership and hiring the right talent, it CAN be done.
• There were housekeeping and punctuation changes to Exela Pharma Sciences, LLC. of Lenoir, NC and Denver Solutions, LLC (DBA Leiters Health) of Englewood, CO, including a conversion of their FMD-145 announcements (previously mentioned here) to “live” hyperlinks.
• INTACT PHARMACEUTICALS LLC of New Milford, CT changed its answer to “Intends to Compound Sterile Drugs From Bulk Drug Substances” from “No” to “Yes.”
• Maitland Labs of Central Florida based in Orlando, FL had its “Initial Registration Date” and “Most Recent Registration Date” fields updated and corrected.  They had previously been entered in reverse order.
• Medi-Fare Drug of Blacksburg, SC had its status updated from “Open” (483) to “Untitled Letter Issued 3/18/2019.”
• Nephron Sterile Compounding Center, LLC (NSCC) of West Columbia, SC had its status updated from “Open” (483) to “FMD-145 Letter Issued 5/15/2019.”
• Nubratori, Inc. of Torrance, CA had its status updated from “Open” (483) to “FMD-145 Letter Issued 5/15/2019.”
• Pacifico National (DBA Amex Pharmacy) of Melbourne, FL had its “Date of Most Recent Inspection” updated from 1/21/2016 to 5/31/2019, but the field “Was a 483 Issued at Most Recent Inspection” remained set to “Yes.”
• Pentec Health of Boothwyn, PA had its “Date of Most Recent Inspection” updated from 2/23/2018 to 5/30/2019 and the field “Was a 483 Issued at Most Recent Inspection” was updated from “Yes” to “No” which I interpret as meaning they had a clean inspection, so congratulations to Pentec.
• All four PharMEDium sites (Cleveland, MS, Dayton. NJ, Memphis, TN, and Sugar Land, TX) had their “Date of Most Recent Inspection” field updated to 11/12/2018.  The status field for Memphis updated to, “Ceased sterile operations under consent decree of permanent injunction – 5/22/2019,” while the other three locations updated simply to, “Under consent decree of permanent injunction – 5/22/2019.”  (Note that even though Cleveland MS has not ceased per FDA, its de facto cessation occurred with the massive layoff I’ve already reported on here.)
• QuVa Pharma, Inc. of Bloomsbury, NJ had its “Date of Most Recent Inspection” field updated from 11/30/2017 to 5/31/2019 and its “Was a 483 Issued at Most Recent Inspection” remained set to “Yes.”
• Quva Pharma, Inc. of Sugar Land, TX had its “Date of Most Recent Inspection” field updated from 6/2/2017 to 4/23/2019 and its “Was a 483 Issued at Most Recent Inspection” remained set to “Yes.”  Its “Other Action Based on Last Inspection” field updated from “FMD-145 Letter 8/20/2018” to “Open,” reflecting their new 483.
•  SCA Pharmaceuticals of both locations (Little Rock, AR and Windsor, CT) had their “Other Action Based on Last Inspection Fields” updated from “Regulatory Meeting – ” to “Regulatory Meeting – 3/5/2019.”
• SSM Health Care Corporation of Fenton, MO and STERRX, LLC of Plattsburgh, NY each had punctuation changes in their “Other Action Based on Last Inspection Fields” (hyphen inserted between text and date) but no material change.

6/19/2019 – More edits were made to ROFs just four days later and these were:

• BayCare Integrated Service Center, LLC (DBA BayCare Central Pharmacy) of Temple Terrace, FL made its debut appearance on the ROFs page.  My congratulations to Ken Jozefczyk and Baycare leadership for putting in the hard hours to get their facility across the line and having hired a world-class expert GMP firm to guide their steps.  Their date of registration was listed as 6/4/2019 and their result of most recent inspection field was set to “Not yet inspected.”
• Premier Pharmacy Labs Inc of Brooksville, FL had its “Date of Most Recent Inspection” field updated from 6/13/2016 to 6/12/2019 and its “Other Action Based on Last Inspection Field” updated from “Regulatory Meeting – 1/31/2018” to “Open” to reflect the issuance of a 483 at the 2019 inspection.  I expect that will change from “Open” to some language to reflect their current recall by the next update of ROFs.
• RXQ Compounding LLC of Athens, OH had its “Date of Most Recent Inspection” field updated from 8/8/2017 to 6/6/2019 and its “Other Action Based on Last Inspection Field” updated from “Regulatory Meeting – 05/23/2018” to “Open” to reflect the issuance of a 483 at the 2019 inspection.  (Note: I believe the fact that both Premier and RXQ had their “Action Based on Last Inspection” updated to “Open” does not erase their “Regulatory Meeting” status.)  As with Premier, I expect that RXQ’s status will change on the next update from “Open” to a recognition of RXQ’s current recall.

CIRoA

There were two sets of updates to CIRoA since my last newsletter:

05/20/2019 – This update included 100+ lines I had to review, and, in May, I mistakenly thought the changes were purely housekeeping and punctuation changes.  For instance, 48 of the action edits were merely the insertion of an “external link disclaimer,” which is a warning that clicking on the hyperlink takes the user out of FDA.gov.  Many other edits were merely punctuation changes or the insertion or removal of a “space” but there WERE 24 actual edits that I overlooked.  Here they are:

• Apollo Care of Columbia, MO (a 503B) received a Warning Letter on 3/20/2019
• Atlas Pharmaceuticals LLC of Phoenix, AZ (a 503B) received a Warning Letter on 9/11/2018
• BMD Skincare Inc of Canoga Park, CA (a 503B) was issued a 483 on 3/5/2019
• Brookfield Medical/Surgical Supply, Inc., Brookfield, CT (a 503B) was issued a 483 on 12/21/2018
• California Pharmacy and Compounding Center, Newport Beach, CA was issued a 483 on
• Coram Healthcare Corp. of Indiana, Crown Point, IN was issued an FMD-145 Letter on 3/7/2019, many months after it was closed
• Crawford’s Professional Drugs, Inc., (DBA Diket’s Professional Drugs, Inc.) of Laurel, MS made its first-ever appearance on FDA.gov with the issuance of a 483 on 11/29/2018
• CSRX Inc., (dba Rushmore Compounding Pharmacy) of Rapid City, SD was issued an FMD-145 Letter on 2/19/2019
• Drug Crafters, L.P. of Frisco, TX was issued a State BoP Referral Letter on 02/11/2019
• Health Solutions Pharmacy Center, Inc. of Corvallis, OR made its first-ever appearance on FDA.gov with the issuance of a 483 on 01/28/2019
• Humco Holding Group, Inc. of Texarkana, TX made its first-ever appearance on this webpage although I shouldn’t speculate regarding this entity’s history.  I suspect (but am not sure) that this is a pharmaceutical manufacturer/API supplier, not an actual compounder an it seems to be a “square peg in a round hole” on the CIRoA webpage.  Regardless of the entity’s pedigree, it received a Warning Letter on 1/26/2017
• Hydrid Pharma of Deerfield Beach, FL (a 503B) received a Warning Letter on 11/30/2018
• Infusion Partners, LLC of Canfield, OH received a Warning Letter on 3/20/2019
• Intrathecal Compounding Specialist, LLC of Scott, LA was issued a 483 on 2/14/2019
• La Vita Compounding Pharmacy LLC of San Diego, CA received a Warning Letter on 2/18/2019.
• Lifetime Value Pharmacy III Inc. of Santa Ana, CA made its first-ever appearance on FDA.gov with the issuance of a 483 on 2/21/2019
• Maplerose Enterprises, LLC (dba Pencol Pharmacy), of Denver, CO was issued a 483 on 2/26/2019
• Millers of Wyckoff, Inc. of Wyckoff, NJ was issued a State BoP Referral Letter on 2/26/2019
• One Way Drug, LLC, (DBA Partell Specialty Pharmacy) of Las Vegas, NV received a Warning Letter on 3/13/2019
• Pharmacy Resources Incorporated of Denver, CO was issued a 483 on 1/29/2019
• Pharm D Solutions, LLC, of Houston, TX was the subject of two press announcements.  The first was a firm press release on 9/10/2018 of a voluntary nationwide recall and the second was an FDA Alert not to buy products from Pharm D Solutions, which read, “FDA issued a warning letter to Pharm D in December 2016 following an inspection. During FDA’s recent follow-up inspection of Pharm D’s compounding facility in August 2018, investigators observed insanitary conditions, including poor sterile production practices and deficient environmental monitoring. These conditions raised concerns about the company’s ability to assure the sterility of its drug products.  On September 10, 2018, following FDA’s recommendation, Pharm D recalled all unexpired drug products intended to be sterile and agreed to cease sterile operations until it makes adequate corrections at its facility. However, Pharm D resumed sterile operations on October 8, 2018, and distributed purportedly sterile products without making adequate corrections at the facility. Pharm D agreed to cease sterile operations again on November 9, 2018 but has not agreed to FDA’s recommendation to recall all unexpired drug products intended to be sterile. These compounded drug products could put patients at risk.”
• Ranier’s Compounding Laboratory of Jeannette, PA was the subject of Press Release that The U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against the pharmacy and its owner
• Triad Rx, Inc. of Daphne, AL received a Warning Letter on 2/5/2019
• US Compounding Inc. of Conway, AR was issued a 483 on 2/7/2019

On 6/27/2019, there were several more updates, including SEVEN WARNING LETTER CLOSEOUTS!  Since this is like spotting seven unicorns, we can conclude that this represents a special cause of variation on the part of FDA and it’s a welcome difference.

• Warning Letter CloseOuts:
  • ARJ Infusion Services, Inc. of Lenexa, KS received a Warning Letter CloseOut, an FMD-145, and a SBoP Referral Letter all on 3/6/2019, so congratulations to them
  • Buderer Drug Company Inc. of Perrysburg, OH was issued a 483 to its Avon OH location on 2/14/2019 and received a Warning Letter CloseOut for its Perrysburg location on 5/1/2019, so congratulations to them
  • Jeffreys Drug Store of Canonsburg, PA received a Warning Letter CloseOut on 8/16/2018, so congratulations to them
  • Millers of Wyckoff, Inc. of Wyckoff, NJ received a Warning Letter CloseOut on 2/2/6/2019, so congratulations to them
  • Pensacola Apothecary Inc., (DBA Everwell Specialty Pharmacy) of Pensacola, FL received a Warning Letter CloseOut on 4/22/2019, so congratulations to them
  • Professional Arts Pharmacy, Baltimore, MD received a Warning Letter CloseOut on 3/11/2019, so congratulations to them
  • Spoonamore Drug Co., Inc., (DBA Louisville Pharmacy) of Louisville, KY received a Warning Letter CloseOut on 5/17/2018, so congratulations to them
• Other welcome events
  • People’s Pharmacy, Inc. #2 of Austin, TX received an FMD-145 on 3/12/2019
  • WellRx, LLC (DBA HomeRx, LLC) of Wheaton, IL was issued an SBoP Referral Letter and an FMD-145 Letter, both on 4/3/2019
• Unhappy events
  • Premier Pharmacy Labs, Inc., (dba Rx Nations) of Weeki Wachee, FL issued a Firm Press Release announcing a Voluntary Nationwide Recall of all Unexpired Drug Products
  • RXQ Compounding, LLC of Athens, OH issued a Firm Press Release announding a Voluntary Nationwide Recall of All Sterile Products within Expiry on 6/18/2019
  • John’s Pharmacy, Inc. of Sullivan, IL was issued a 483 on 2/22/2019
  • Option Care Enterprises, Inc., (DBA Option Care) of Little Rock, AR was issued a 483 on 3/12/2019
  • QuVa Pharma Inc. of Temple, TX was issued a 483 on 3/14/2019
  • Rocky Mountain Pharmacy Inc of Bozeman MT received a Warning Letter on 5/9/2019
  • ImprimisRx CA Inc. (DBA ImprimisRx) of Irvine CA was issued its second Warning Letter on 3/26/2019.

FOIA

As of the morning of 7/3/2019, no material updates since April 2019.  (No longer true as of the sending of this newsletter.  FDA posted a new hyperlink, which was labeled as a 483 but unfortunately led me to a search page).  When they do update FOIA for real, it may drown us.

Other News
There are too many “other news” issues to cover, but here are several with more to come soon:

• WalMart pharmacy reduction-in-force
  • Walmart cut nearly 1,000 of its pharmacy-based workforce last week.  Their reported intention is to take headcount down by about 3% across the board over the next six months while eliminating up to 40% of their most senior pharmacy folks.  Huh?!  How could this possibly be? 
  • The better question is how could it possibly be avoided?  The biggest surprise to me is that it took this long.y
  • I had the cold, hard facts laid out for me by Dr. Mary Graham (retired Dean of the Butler University CoP) when we were first getting acquainted in June 2014.  The building of so many more brick-and-mortar colleges of pharmacy than the market would justify had doubled the number of board-ready graduates from 7,000 in 2001 to nearly 14,000 in 2014.  We shouldn’t need a sliderule to draw conclusions from that statistic.
  • So now, it’s coming home to roost and I expect it to accelerate. The Big Three (CVS, Walgreens, and Walmart) are moving to apply automation and telepharmacy to the new models of care delivery and completely revise the landscape of pharmacist and technician employment.  I’ve read accounts from now-former employees that WalMart will likely allow them to reapply for the new-model jobs on or after 60 days of separation.
  • Here’s a prediction quiz for how it will look to those hoping to be rehired after the 60 days.  If some portion of the staff rehire, do you expect that they will find that:
    • (1) the requirements of productivity measures will be higher? or lower? 
    • (2) pay-per-unit-time will be higher? or lower?  (A cynic might start to wonder whether financial support from the big pharmacy chains in building so many pharmacy schools so rapidly was out of the goodness of their charitable hearts or based on the long view of meeting their corporate salary goals.)
• A good friend of mine whose company distributes large quantities of drugs and medical supplies into every state told me that the Minnesota Board of Pharmacy fees for wholesaler/distributor permit renewal is increasing from less than $400 to $5,260.00 per year.  It’s good to be a government, isn’t it?  Way better than being a private business scrapping for survival!
• On May 21, I attended a meeting at FDA’s White Oak Campus called, “Public Meeting on Outsourcing Facilities, CGMP, and Office Stock.”
  • There were serial presentations/testimony in a couple of groupings:
    • First were the frustrated ophthalmogy groups (Cornea group, Retina group, Lens group) who are wearly of the roadblocks FDA enforcement policies put the way of their trying to cure patients.
      • The eye doctors were clearly frustrated with FDA’s tightening the noose on vitally needed compounds, but I wonder how they’re feeling now with the spate of recent FDA recalls and actions being centered on the Avastin aliquoting aspects of 503B ROFs?
      • I wonder how they’re feeling now
    • Second were discussions of the 503B API Bulks List, with formal presentations by Lee Rosebush and A.J. Day.
  • There was a very important statement at that meeting made by FDA’s Ian Deveau, Ph.D. 
    • I believe I heard that Dr. Deveau has his Ph.D. in Extremophilic Microorganisms.  I’m certain that he has a tremendous influence on FDA’s policies regarding whether processes are compliant with Current Good Manufacturing Practices.
    • In response to feedback from an audience member that it is very difficult for ROFs to obtain Certificates of Analysis from FDA pharmaceutical manufacturers,  Dr. Deveau addressed that question head-on.  He said that if a 503B ROF is producing sterile preparations from FDA-Approved, marketed sterile products, there is no need to obtain a certificate of analysis from the drug maker.  Instead, he said the FDA approved labeling (package insert) IS the CERTIFICATE OF ANALYSIS.
    • At the next break, I was able to show Dr. Deveau at least one instance in which a 503B ROF had received a 483 Observation that very issue.  He said it was an inappropriate Observation and would be stricken from 483s if it’s cited again.
    • Dr. Deveau was willing to repeat that statement a month later for the attendees at my presentation at the CBI Conference in Silver Spring on June 20. There was visible relief on the part of some of the 503B ROFs in the room.  The bottom line is – if confronted by an FDA Investigator demanding to see a COA for a marketed drug, just ask them to check with Ian Deveau.
  • One more thing I want to mention about the CBI Conference.  We not only had FDA represented by Gabrielle Cosel and Ian Deveau, the third speaker was John Claud, JD, Assistant Director of Consumer Protection at the Department of Justice. 
    • Mr. Claud gave an informative and insightful presentation and I learned a lot from it, but when it came time for Q&A, my new friend, Jake Olson stepped to the microphone.
    • Jake is the owner of Skywalk Pharmacy, which has three locations, each one situated inside a hospital building of The Childrens Hospital of Wisconsin (Greater Milwaukee).
    • Jake thanked Mr. Claud for the informative presentation and noted that it was very sobering and awe-inspiring.  He said that it was so awe-inspring that he was going to immediately alter his own professional practices.  He said he very often draws up FDA-approved insulin and make dilutions that match the needs of the overwhelmed parents who must administer precise doses to their tiny, underweight premature infants.  He prepares these dilutions without the benefit of a cleanroom or an ISO Class 5 device the way many practicing pharmacists and physicians have done for our long careers.  He said when he gets back home, he’s going to hand these frazzled parents a full-strength insulin vial, an empty sterile vial, some diluent and syringes, and he’s going to explain how to perform their own dilutions.
    • Mr. Claud, who seems like a very decent person, just trying to protect the public health, assured Jake that such practices are never what DOJ or FDA are looking to bring to heel.  I liken Mr. Claud’s statements to, “you are not the droids we’re looking for.”
    • Jake said he accepted that assertion as absolutely true, but realistically noted that if anything ever went wrong and a baby were injured after he made such a preparation, in today’s regulatory environment, nobody – not even DOJ – could assure him that his business, his income, his professional license, his family’s future, or even his liberty would survive.
    • In the moments that followed, I sat and struggled with my own “current thinking” on the quandary Jake articulated.  We really have come to this point in the evolving regulatory landscape where caregivers are becoming paralyzed and afraid to provide care.  There is simply too much uncertainty right now and patients’ health is going to suffer setbacks and some will even die due to these seismic regulatory shifts.  FDA believes it’s protecting the public health by trying to impose manufacturing standards on professional practice.  Their primary goal is to protect the public from harm from drugs, but the most obvious way to achieve that is to prevent them from receiving any drugs.  I believe we need to step back and weigh the relative risks of imperfect medications versus unavailability of drug therapy and get back to some semblance of common sense and balance.  Life is full of risk.  We can never eliminate risk – we can only mitigate it.

There are a large number of new readers who’ve signed up since the most recent newsletter.  FYI, I usually go through each 483 to say how many FDA personnel were recorded on the Form, how long they were on-site (if I can determine it), how many Observations were recorded, and sometimes I add my thoughts about the implications of document. 

I also usually include hyperlinks to each and every update to CIRoA, FOIA, CRAs, ROFs, and WLs so you can read them. 

I just don’t have the time to do either activity tonight, but I hope to catch up to this over the weekend if possible.  In the meantime, you can get to those hyperlinks – if they exist – if you want to read them on your own.

Finally, if you know of any Avastin producing ROFs or pharmacies with FDA in, please e-mail me with details and the number at which you can be reached.