What's next for the FDA with regulating iPharmacies?

(by Patrick Harris, Business & Technical Project and Product Manager for the Digital Age)

About six weeks ago, the FDA set precedence when they took action against a dietary supplement maker that used Facebook to “Like” an unapproved claim regarding one of its products.  In this Warning Letter, FDA cited a multitude of serious violations against the marketer of a drug product called Poly-MVA. The company had sold its product through the use of testimonials that were not substantiated by good science, according to FDA.

Just one week prior to this, the FDA issued a warning letter to a drug maker over that company’s use of a search bar on its web site. The FDA faulted the firm for improperly linking disease queries directly with drugs that the company marketed.

The FDA has historically been reluctant to publish clear guidance when it comes to how it regulates promotion.  With the speed of the web, must they adapt their traditional governing principals?  If they have plans to regulate Internet Pharmacies starting with promotion regulations, what’s next?

Going back a few months to October 2012, we noted a new FDA campaign - “BeSafeRx - Know your Online Pharmacy".  The FDA BeSafeRx is a national campaign to raise awareness of the dangers of buying prescription medicines from fake online pharmacies. This campaign provides the resources to help consumers: (1) Know the Risks - Learn the Dangers of Buying from an Online Pharmacy (2) Know the Signs - Identify the Signs of a Fake Online Pharmacy (3) Know your Online Pharmacy - Find a Safe Online Pharmacy.  Was this the first hint of regulation by establishing a consumer baseline of sorts? 

There is no question that the FDA is seeking to keep up with the demands and fast-paceness of the digital age with the goal of protecting consumers.  However, the warning letters are just the start.  Also, look for external guidance for third-party organizations such as the Alliance for Safe Online Pharmacies (ASOP).  

In my option, Online Pharmacies should take proactive action in protecting themselves.  This includes keeping extremely current with forthcoming guidance from the FDA.  There will probably be more of these types of warning letters in the near future.  Online pharmacies should operate within this guidance and have the Standard Operating Procedures in place and documented.  In terms of Social Media, this means creating more private networks that are less than ‘socialable’ (just to be safe).  In efforts to offset this regulation by the FDA, online Pharmacies should also familiarize themselves with the manufacturers promotion of such items as their advertisements are heavily regulated.  Internet Pharmacies can also take note from the Pharmaceutical, Clinical and related drug development industries.  These very tight regulations will likely trickle down in various forms, particularly the regulations related to consumer promotion.

For more information about PharmaSys, please visit our website at www.pharma-sys.com.

Medical Devices and Analytical Test Methods

(by Patrick Harris, Business & Technical Project and Product Manager for the Digital Age)

The following case and questions were posed to a PharmaSys employee: "Hi, I am in the middle of writing a validation plan for year 2013. I have a little problem because there is a lot of testing methods/measurement systems inside the factory but  the procedure for validating analytical/test methods is not applicable, and I don't have analytical methods inside the factory because i'm in medical device not pharmaceutical industry. Does FDA clearly divides test methods, analytical methods and measurement systems and requires validation for all of them?  Can anyone comprehensively comment on this topic?"

The FDA Quality System Regulation in 21 CFR 820 are pretty generic in regards to validation requirements for medical device manufacturers.  Design validation (820.30) and Process validation (820.75) are the two main requirements covering validation of medical devices.  Nowhere are test method validation, analytical method validation, or measurement systems validation specifically outlined as requirements.  However, it should be understood that the process validation requirement in 820.75, although vague, has significant impact on the validation requirements.  The FDA expects any part of the manufacturing process to be validated.  This could include analytical/test methods.  Requirement 820.72 states that “[e]ach manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results”.  The wording used here is critical; “suitable for its intended purposes” means that the equipment has well-defined specifications and that those specifications have been verified and found to be acceptable (this is validation).  Depending on the piece of equipment and its use, it is possible that calibration may be all that is required to meet the intent of 820.72; but this decision should be documented.

Specifically related to your question, you should assess each of your test methods and measurement systems to determine the level of validation required (if any).  The key will be to document the assessment and your decision to validate (or not validate) in your validation plan.  If something will not be validated, you need to provide a rationale for why it will not be validated (e.g. system will be calibrated only and will be routinely challenged).

Some other resources that may be of use to you would be the FDA guidance on analytical procedures and methods validation (http://www.fda.gov/downloads/Drugs/.../Guidances/ucm122858.pdf) and ICH guidelines on validation of analytical procedures (ICH Q2) at http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.  Although not specifically related to medical devices, you can glean some information on the industry’s stance in relation to these topics from some of these documents.

For more information about PharmaSys, please visit our website at www.pharma-sys.com.

PharmaSys Quick Case Guide to Social Media Recruiting

(by Patrick Harris, Business & Technical Project and Product Manager for the Digital Age)

PharmaSys Senior Consultant, Craig Morgan has been hard at work with some business development and recruiting efforts in this last quarter of the year.  He sent me the following email and I thought it was an interesting blog topic - especially for consultants leveraging social media (in this case LinkedIn) for recruiting purposes:

"I am looking for some help from you to revise/update my Linked In account. I want to develop our business in the Boston area and don’t really know how to utilize LI as an effective tool. My gut tells me there are people out there who scour these sites and some modifications to my account could put me/us on their radar."

Here's my response with hopefully some quick tips to help you use this free recruiting tool:

Here are a few first initial tips to get started.

"For your current LinkedIn profile,

(1) Add Skills to your Profile.  LinkedIn has this functionality.  Add all/any skills related to your profession and this will give you more "Klout" on the site and increase your search ability.  Also, add more summary information (maybe from your PharmaSys CV).  

(2) Post Relevant Content Consistently.  You want to post industry news or commentary that is relevant, frequently.  This does not have to be original content but something you want to share i.e. a new story, study, etc. to your updates.  The key to this is do it frequently.  I would suggest having a schedule and sticking to it (i.e. daily, 3 times a week, etc.).  

(3) When you post, Optimize Search.  Right now since you have a specific target, I would always include the hashtag #Boston in my updates/posts.  I always include the hashtag #pharmasys in my posts as well.  The association of the two will help increase your search visibility and ultimately help connect you to interested professionals.

(4) Join Groups.  Below I've listed a variety of groups, both geographical and general industry.  Start by joining these groups.  You have the options to receive notifications.  I like the notifications because these give you a chance to respond to these discussions quickly.  I think posting your expertise to some of these discussions would be extremely valuable."

Any other suggestions?

For more information about PharmaSys, please visit our website at www.pharma-sys.com.

A #PharmaSys Commentary on Compounding Pharmacies

(by Patrick Harris, Business & Technical Project and Product Manager for the Digital Age)

There has been a lot of talk recently regarding the Meningitis outbrake linked to a compounding Pharmacy around the PharmaSys office lately (as one can imagine).  As experts in FDA regulations and compliance, it has been a hot topic internally.

Hal Sanborn, Vice President at PharmaSys, presented the following quote: "You're the grand poobah of the FDA and I'm asking you, 'could you have prevented this tragedy?' and you're saying you couldn't have because you don't have jurisdiction."  Rep. Cliff Stearns, R-Fla. on the meningitis tragedy and FDA's oversight of compounding companies.

Naturally, this presented the following questions and thoughts: Any thoughts on the regulations related to this?  Did the FDA in fact have a duty to act?  In your opinion, what is the first step compounding pharmacies need to make to comply with current or forthcoming regulations?

Charles Lankford (@CLLankford), CEO of PharmaSys, had this to say:

"My Opinion:

The FDA does not have jurisdiction over compounding pharmacies. It’s a loop-hole in federal laws intended to allow pharmacies to customize compounds for an individual. The problem is that it’s open for abuse by greedy corporations who are willing to circumvent patient safety for the sake of profit and may be outdated.

I believe that the FDA does have a duty to act on illegal compounding  pharmacies  but it’s a complex problem. The FDA is under-funded and with their current resources, it’s near impossible for them to investigate whether or not every compounding pharmacy meets the intent of regulations or are in-fact drug manufacturers operating illegally.

Additionally, the only reason that the FDA had authority to inspect the compounding pharmacy in question was the fact that drugs were killing people and shipped across state lines. Without that prerequisite the FDA could not act.

We need more stringent federal laws that allows the FDA to regulate compounding pharmacies and more funding to enable them to provide the proper oversight."

Hal provided some additional background from Fox News background and comments by Hamburg

""The challenge we have today is that there is a patchwork of legal authorities that oversee the regulatory actions we can take," said Hamburg, who was nominated to head the FDA by President Obama in 2009.

Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. They are typically overseen by state pharmacy boards.

In the last two decades some compounders, like the NECC, have grown into large businesses that ship thousands of doses of drugs to multiple states. Hamburg said that when her agency tries to intervene in those cases they face a "crazy quilt," of court rulings, which are split on whether the federal government has authority over pharmacies.""

Hal then commented:

"So essentially – Yes, I agree with Charles, it may not be as much they are underfunded and under resourced as much as tied up in the courts by those seeking to extract a profit at the cost to those they profit from (Much higher than the original dollars exchanged)."

What are your thoughts?

For more information about PharmaSys, please visit our website at www.pharma-sys.com.

The Importance of Customer Service for Consulting Professionals

(by Patrick Harris, Business & Technical Project and Product Manager for the Digital Age)

Customer Service is defined as "the provision of service to customers before, during and after a purchase."  While most of us are familiar with this concept from a consumer perspective, let's examine it from the consultant perspective (and what it means for building and maintaining a challenging, fulfilling and lucrative career or business).  As consultants we are expected to be subject matter experts, meet client demands and deliver(!).  Among the craziness we are divulged in, combined with the clients we are involved in along with the problems we must fix, it's tough to keep your head sometimes.  However, one must do it with a smile.

Excellent Customer Service for Consultants includes:

• Providing individual industry knowledge to past and current customers (via email, newsletters, webcasts, social media, in-person dialogue, etc.).
• Following up after a project is complete (even if all deliverables were met) to ensure smooth transition or to answer any questions.  You could also discover additional work opportunities or gain referrals.
• Being open and aware of out of scope "problems" but provide value-add services when you can.
• Dealing with internal politics diplomatically (at all times).
• Leading by example.
• Over-delivering on deliverables.
• Having a positive attitude always; be pleasant to work with.

Customer service must be at the forefront of a consultants mind.  Do the best job you can at it while being consistent and the benefits will follow.

For more information about PharmaSys, please visit our website at www.pharma-sys.com.

A Few (Somewhat Behavioral) Interview Questions to Ask Quality Professionals

(by Patrick Harris, Business & Technical Project and Product Manager for the Digital Age)

I've had the opportunity to work in a variety of technical focused and business oriented roles in the healthcare and life sciences space.  Whether involved in the trenches of a product or service (or somewhere in between), Human Capital LIfecycle Management is increasingly important and complex.  To provide focused value, let's focus initially on the recruiting aspect of Quality Management Professionals.  Here are five questions I have frequently asked, been asked or might ask in the future.  I provide a little bit of commentary on why I like them.  Feel free to add to the commentary.

1.  In past and current job duties, how important is attention to detail and how do you deal with these intricacies when managing the execution of the bigger job at hand?

I like this sort of question(s) for several reasons (1) obviously details are important to the successful quality professional so if they act like it's not important then this is a red flag - either they are completely in 'management' mode unwilling to get their hands dirty - look for a balance.  (2) The last part I like because it can show insight into a candidates vision, motivation and character.

2.  How do you manage multiple project demands from multiple clients?

I like this question particularly for consulting professionals, especially those that have never worked in a consulting capacity.  I've interviewed several candidates that are so single-tasked focused or used to a more traditional corporate environment where this is OK.  However, I look for candidates that can handle multiple priorities - both business and technical from a variety of (demanding) clients.  When candidates answer this question, look for the logic - if it fits into your methodology its a gauge of motivational fit.

and speaking of motivational fit...

3.  In previous jobs and companies you worked for, is there one you felt you fit in best?  Why?

I bring this question up because from my experience, motivational fit is the hardest to screen for.  However, the better this fit, the more profitable the venture is for both parties.  Everybody on the hiring team needs to be on the same page in terms of the core values of the company and the attributes to match the motivation for employment at your specific company.

4.  In general, what types of projects do you like to work on and can you give me a concrete example of a project you worked that fits this mold?  What was your role in the project?

Although this question might be a little long winded, It is a way to connect a candidates dreams with reality.  If the real-world example project they use is totally different from their ideal project, then they might not really like the reality of the job.

5.  Ideally, how do you like your workday to flow?  At the end of the day, what do you like to accomplish?

Yes - a little open-ended but OK.  These questions or ones like them provide insight  into the preferred work environment of the candidate.  Use this to gauge how well the candidate will perform under the day-to-day operations and logistics of the job.  The last question can help gauge the type of management needed for the candidate.  

A few notes:

• Always, even in times of immediate needs, map out the job requirements and collectively, as a team, understand this mapping.  Have a plan to collectively screen the right candidate.
• STAR -  Situation. Task. Action. Result.  I don't suggest, at least initially, requiring your candidates to answer in this format, but probe and coach to help candidates adhere to this model.  A good interviewee will be trained in adhering responses to this model.  

The entire lifecycle recruiting management of quality professionals is increasingly complex, complicated and competitive.  A repeatable, continuous process is a necessary business implementation.  

For more information about PharmaSys, please visit our website at www.pharma-sys.com.