While many in the social media and healthcare community had hoped for grander offerings from the FDA,  they have tackled a clear danger. Besides, any action on social media for the FDA is a good thing, as much ambiguity still exists on what constitutes proper behavior by drug companies online. A bit of housekeeping for those unfamiliar with the FDA’s jargon: the term “off-label” refers to uses of a drug or medical device that is not sanctioned by the FDA. In the normal course of drug and medical device development, once the FDA approves such  items, they are approved for a particular indication. So if a drug is approved to treat headaches, for example, that means it is only approved for that use. Any other purpose would have to be separately studied through rigorous clinical trials to obtain approval.

Online chatter regarding drugs and devices sometimes includes references to uses that lie outside the official FDA sanction. Whether on a blog or a medical site, there are plenty of places to read someone’s opinion about how a given drug or device has helped them with some medical ailment which may not be a use listed on its official label. While doctors commonly prescribe approved drugs for uses other than their intended original purpose, no drug company can promote off-label uses.  The risk of someone using a drug or device for an off-label purpose discovered online could present a dangerous situation and has drawn the FDA’s attention to create its guidance. When a person requests information about an off-label use of a given drug or device, the manufacturer now has a set of directions on how to handle that matter.

When does the guidance kick into play? If a person privately requests information about a drug or device directly from the manufacturer or if the request is publicly announced (online or at a public setting), then an “unsolicited request” has been made. The FDA broadly construes a public-generated request to include those, “directed to a firm specifically or posed to users of a discussion forum at large.” This grants pharmaceutical organizations a wide berth to weigh in even if the requester was chatting to others on an open forum.

By the way, if pharma companies receive solicited requests, then the companies are obligated to respond—this has always been the case. This includes situations where the drug/device company has invited patients to post YouTube videos on how they used a drug or device, which in turn triggered requests for information about off-label use or resulted in videos showcasing off-label use. The same is true if a drug company posts clinical study results that suggest off-label use of its product as being safe and effective which spurs questions  from the public regarding off-label uses. Basically, if the drug/device company incites or provokes questions about off-label use, then it must respond. In contrast, the new guidance pertains to unsolicited requests and gives drug/device manufacturers direction on handling these situations if they choose to respond.

The FDA has always granted drug makers the power to provide, “truthful, balanced, non-misleading, non-promotional, scientific or medical information that is responsive to the specific request,” concerning their products. Moreover, no matter how the request was made, publicly or privately, when pharmaceutical companies choose to respond to unsolicited requests, those responses must be made privately to the inquiring individual.

The FDA advises that when responding to an unsolicited private request, the pharmaceutical company should make sure the communication be privately sent to the person making the request and that it answer only the questions posed. So, if someone asked about an off-label use of product “x”, then the company should answer that without elaborating on other off-label topics regarding the product. The FDA goes so far as to encourage a narrower definition of the question even if it is broadly phrased. However, the FDA makes an exception when it comes to the risks posed by the product.  So, if a given product poses known or suspected risks that bear relevance to the person’s question, they must divulge that information. This is common sense that keeps the public safe and the drug companies honest.

The FDA requires that the, “Information distributed in response to an unsolicited request should be truthful, non-misleading, accurate, and balanced.” That means providing information that casts doubt on the safety and efficacy of an off-label use. Providing medical texts and scientific peer-reviewed journal reprints are advised so reliable information gets in the hands of the person seeking valid answers. The agency further instructs pharma companies to use a scientific tone and to avoid gimmicky promotional messaging. To ensure the last point is credibly undertaken, the FDA has advised that the responses, “should be generated by medical or scientific personnel independent from sales or marketing departments.” This is a brilliant stroke by the agency, though this could result in highly academic communications that are too obtuse to be understood by the lay public. Nevertheless, this is a move in the right direction that shields the public from slick marketing.

As part of any formal response, the FDA encourages the provision of the official label, a prominent statement that the off-label use is not approved, a clear statement for which uses the product is approved, safety information, and a list of references of all the information provided. Finally, the FDA advises that all responses be documented by noting the nature of the request, the contact information of the person seeking the information, what information was provided, and any follow-up inquiries or questions from the requester.

When a pharma company encounters questions regarding off-label use of its product online (as on public website or social media forum) it can choose to respond in the following manner:

•  It can provide the firm’s contact information, inviting the requester to seek more information from their medical advisor, but cannot provide off-label information in that same public forum.
• The contact information provided to the requester must be specific to that medical or scientific personnel (e.g. e-mail address, telephone number, facsimile).
• Recordkeeping requirements described above also apply here.
• When a pharmaceutical company chooses to respond to an online episode of an “unsolicited request,” that company representative must identify himself when providing the contact information.
• These responses cannot be promotional in nature.
• Direct links to the current FDA-required labeling should be provided, but no other links (e.g. product websites). The sites where FDA-required labeling is available cannot be promotional either, so you can’t have a URL that reads “www.TheCureForCancer.com”)

Taken altogether, the FDA has given a clearly defined set of actions on how to handle unsolicited off-label questions. This draft guidance was issued on December 27, 2011, so the public has 90 days within which to respond provide feedback to the FDA. So for now, this is merely suggestive, not mandatory, but has provided a transparent view of the agency’s direction.

The post is long, but provides an overview of Dr. V’s approach to social media.  If you review his blog, you will see that this post (and the related presentation) neatly summarizes what Dr. V recommends as best practices to using social media.  I think it is a good read…but I do not agree entirely with his recommendations and conclusions.

I think it is easiest to start with the areas where I see that we are on common ground:

• I agree that medical care in the future will be a very different culture than it has been in the past.  Technology and patient empowerment have already changed the way we practice, and will continue to do so.  The e-patient movement and the interconnectedness allowed by social media will further encourage patients to find out about their own illnesses, research treatment options, and discuss these issues with their physicians in different ways than has been the case up until now.  Patients are already changing the nature of this dialogue, and health care will need to adapt accordingly.
• I also agree that the nature of social networks–varied sources of information, numerous perspectives, and various analyses–have changed the nature of how we receive information.  Many of us can recall recent major news stories that we first heard through social networks (Osama bin Laden’s death? Congressional budget deals adverting a shutdown?  Kim Jong-Il’s death?), both on the local and the national levels.  I learn about many developments in healthcare reform and clinical practice by following certain key accounts on Twitter: I see this information sooner than I would if I waited for traditional media or (gasp!) the evening news.  There is tremendous value to be found in using social media as a principle source of information.
• Those doctors actively engaging in social media are still the minority.  This is something that needs to change–as noted above, patients are already looking for information on the internet.  If physicians are not there, then we are missing out on being a part of this discussion.
• Finally, I agree that we must protect patient confidentiality and patient information–period.  I do not post/tweet about patients.  Period.  When I speak about “patients” (as I sometimes do on my personal blog) I speak in the aggregate, not as individuals.  Unless one has specific and direct permission to share an individual’s story, then it should not be shared.  I also agree that there is no acceptable way to practice medicine in any way on Twitter or via other social media.  Physicians can provide general information and/or point patients toward publicly-available resources (such as FamilyDoctor.org, or the Mayo Clinic patient information website), but we cannot and must not provide actual medical care via social media.

I disagree with Dr. V on some of his recommendations for how best physicians can properly use social media, though.  It might be that we see these issues from slightly different perspectives or through slightly different-colored lenses, but I think there is value in exploring the differences:

• The largest difference might be around our views of professionalism, and how these views might influence how we interact on social media.  Dr. V notes, and I agree, that separating one’s professional and personal presences online is an incredibly difficult task.  However, the sense I get from his blog post is that he favors restraint and that he favors limiting one’s online presence to that that would be in line with the most professional setting.  In other words, behave online at all times as you would behave in clinic.  This is doubtlessly a safe approach, but where does it leave our personal voices?  Can I discuss politics?  I wouldn’t do that with my patients, but can I do it here?  Can I post silly pictures of me at a gathering of friends, wearing a silly fake mustache and having a beer?  No doubt many of those following my account don’t really care about that photo, one way or the other…but is it unprofessional?  I wouldn’t post it in my office, but is it OK to share here?  Does this violate my professional role as a physician?  I use my accounts to discuss personal interests, not just medical issues.  Can I personalize my account–my voice–without being seen as unprofessional?  Does it make me less professional, or more human?  If I identify myself as both an individual and as a physician, is it wrong to express both aspects of who I am?
• Dr. V and I also differ on the role/value of anonymity online.  I would agree with him that we should not presume anonymity will actually protect us or our patients: I figure most anyone’s online pseudonym can be broken by someone smart enough and with enough time.  So I–personally–do not see the value in anonymity.  However, I do think there can be value in anonymity in certain cases.  What if a physician is criticizing the practices of a major insurer, or their employer?  What if someone wishes to discuss a sensitive personal issue without self-disclosing?  Even if this cloak of secrecy is not foolproof, it can provide a safer space for such discussions.  I think the content of an account will dictate whether or not it is trusted or considered valuable–not just whether or not it is anonymous.  I choose not to be anonymous, but that is my choice.  I can choose to ignore anonymous accounts…and others can do the same.  I do not think this is a one-size-fits-all situation, and I think individual users should have options as to how they can best and most productively engage.
• I have even suggested (in this post) that there can be value in anonymous, “unprofessional” conduct.  Whistle-blowers, agitators, and critics may all have important perspectives and contributions to an issue under discussion, or might call attention to larger problems.  Raising these issues might strike some as unprofessional…raising the question of who will decide professional vs. unprofessional conduct?

This is not to say that anonymity protects anyone’s privacy–it is a cloak, but one that can be removed with enough effort.  Anyone posting controversial or questionable material online needs to be aware of the potential consequences.  As Dr. V notes, doctors have lost malpractice suits, their jobs, and their licenses for posting material online that was sufficiently controversial or that violated patient privacy.  This risk is real, as is the risk that one could face sanctions from professional organizations.  The American Medical Association’s social media guidelines advise that, “[w]hen physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions.  If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities.”  The guidelines do not specify who “appropriate authorities” would be, but it could include hospital authorities, employers, or state-level Boards of Medicine.  There is need for physicians to be careful when interacting online, but this care is required whether one is posting anonymously or under their own name.

Take the @BurbDoc account, for example.  (Warning: this account is often not safe for work.)  BurbDoc posts anonymously, and criticizes much of what he (she?) sees in medicine–often with liberal use of profanity.  Many (most?) would consider this account unprofessional, and many are likely not fond if its existence.  My perspective on the account is that, although I do not personally appreciate everything that the account posts, BurbDoc has the right to post this material anonymously.  From following and interacting with the account, I feel that BurbDoc’s motivation to use social media comes from the right place: to expose inefficiencies and hypocrisy in medicine–especially on the part of insurance companies–of which patients might not be aware, and to discuss what they believe to be patients’ complicity in our dysfunctional system.  Personally, I could do without some of the language, and as a result I rarely share BurbDoc’s posts even if I agree with the sentiment.  But this is BurbDoc’s decision and his choice: he has chosen to use this approach, and he must come to terms with the fact that this choice might limit his audience and could create problems for him down the road.  Physicians who do not approve of this choice can simply choose to ignore the account; after all, BurbDoc does not claim to speak on behalf of anyone else.

I would argue that the best approach is more fundamental than the issue of whether or not we should be anonymous or whose definition of professionalism is most valid.  I think the best approach is this:

• Be nice.  Don’t be a bully, don’t be scornful, don’t be rude.  Be engaging and respectful.
• Be helpful.  When you have useful information or valuable insight, don’t be afraid to offer help or be a resource to the community.
• Be careful.  Remember, as Dr. V has said, that this is all happening in public.  Don’t say anything you would be afraid for others to see…and stand behind what you say.
• Be engaged.  Whatever your purpose for getting involved in social media, you should be here because you are looking to connect with others.  That means that you need to actually engage and connect with them.  Having an account that doesn’t interact with others has little value in my opinion.

I strongly agree with Dr. V’s call for physicians to become active in social media, both in this post in in this earlier post.  I have found there to be enormous value form my social media participation, and I do my best to add value.  But, I do not think that we need to separate or silence our individual voices to do this.  I think we can help each other be careful, and helping newcomers (or perceived outliers) stay out of trouble.  We’re all in this together, for our patients’ health and wellness.  But we are all human, and I think it is fair if our social media presence reflects that.

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Medical education is based on the foundation of science.  Undergraduate premedical majors are required to take a number of science courses in order to be considered qualified applicants for medical school.  Once in medical school, students are exposed through all four years to scientific research: we are taught about seminal basic science experiments that helped establish the biochemical mechanisms, and were are taught about the process of clinical research and how the scientific method has helped develop current medical treatments.

At the same time, as we are steeped in the tradition of science, we do not always do a good job of following the scientific method.  One of the greatest examples is the continued practice of providing antibiotic prescriptions for viral illnesses, despite the clear knowledge that antibiotics will not affect how quickly patients improve.  Even though we are trained to approach questions from the scientific perspective, human nature can impact how reliably we follow evidence-based, scientifically-grounded recommendations.  Often time, the rationales given include either the fact that one might be uncertain about the nature of the illness being treated and/or the claim that patients expect antibiotics and that it is easier (and more customer-friendly) to just give patients what they expect as opposed to standing by the evidence.

The truth is that medical practice is a combination of science and human nature.  Hopefully we lean towards the evidence more often than not, but you cannot deny the human part of the process.  Add in the fact that many physicians are employers, small business owners, and breadwinners, and the balance can become more complicted.  As a result, many of the decisions we make are based on considerations from both sides of the issue.

I believe that this will also be true of efforts that attempt to engage physicians in communicating via social media.  To date, efforts to encourage physicians to engage in social media because it is interesting, fun, etc do not seem to have much traction.  I propose that it will require showing that social media has measurable benefits to patient care (scientific argument) and that it improves practice efficiency and/or practice income (human nature argument) in order to increase physician engagement.

• If research programs that are well-designed, double-blinded studies investigate whether various approaches to social media engagement improve patient outcomes of some sort (disease-oriented outcomes like blood pressure or diabetes control, patient-oriented outcomes such as a global measurement of wellness) and show a beneficial result, then we will have scientifically-based evidence showing that social media can improve healthcare.  This will appeal to our self-perception as scientists.
• At the same time, if it can be demonstrated that using social media improves how medical practices work (fewer calls back, more new patients, more satisfied patients, etc) and if they can increase the efficiency of medical practices (thus reducing costs), then we will have information that impacts the human nature side of the decision: physicians will have more profitable practices, or will be able to hire more staff, or will be able to offer additional services to their patients.  This appeals to the business/professional side of a physician’s worldview.

Needless to say, these two goals are not mutually exclusive.  Often times, interventions that improve medical outcomes also improve practice efficiency…and could become more important as medicine moves towards paying for quality of care as opposed to intensity or quantity of care.  But I think it will take arguments that satisfy our scientific training as well as business needs that will increase physicians’ involvement in social media.

I am currently in California, attending the Society of Teachers of Family Medicine (STFM)’s Practice on Conference Improvement. I don’t have any personal connections with this part of the state, and given the conference’s location in a tourist-focused area there is not much here for me to do outside the meeting. To be honest, I would never have come here if not for this conference. Normally, then, all I would have done would have been to attend the meeting sessions, and then spend a lot of time in my hotel room. I’m fairly bad at mingling, networking, and the like.

This time, though, I mentioned on Twitter that I was coming here. As a result of my ongoing conversations on Twitter–whether in the context of organized Twitter chats, or on the fly–folks in the area contacted me to meet up in real life.

Ben Miller (@miller7) and I co-presented a talk on SocMed at this meeting, so we met up on arrival. Of note, Ben and I met on Twitter, and our ongoing collaborations (talks, the OccupyHealthcare Project, etc) grew out of our SocMed connection…before we had ever met in person.

During the first day of the meeting we met Jay Lee (@FamilyDocWonk), someone we had both been in touch with for nearly a year online. Jay joined us later that night for a tweet-up with Gregg Masters (@2HealthGuru) and Fred Trotter (@FredTrotter) during which we spent a lot of time discussing the nature of the OccupyHealthcare movement…and brainstorming how each of us can contribute to the cause.

This morning, Jay met Ben and I again as we were joined by Mark Harmel (@MarkHarmel). Mark is a photographer and an MPH student, and we had an active discussion abthat opportunities to participate in healthcare reform and system redesign.

Ben, Jay and I went to lunch together, joined by faculty and residents from the residency program where Jay teaches and practices. From this meeting I might have found a resource to help identify physicians who can help in the international healthcare project I help lead.

Finally, tonight Ben and I are having dinner with Carmen Gonzalez (@crgonzalez). I have shared this blog with Carmen and Mark Dimor (@MarksPhone), and have not met either of them in person. I’ll finally remedy that…halfway.

Before I was involved in SocMed, this meeting would have been ho-hum…if I had come at all. Now, I can say that I have met new real-life friends, have strengthened ties with others, and have made connections and discussed new projects that will keep me busy–and thinking–for some time.

One of the criticisms of SocMed is the belief that connections made here are broad, but shallow. I would argue that the breadth of the connections we make via SocMed allows us to interact with people we would otherwise never meet, and that these interactions can develop into meaningful collaborations and friendships.

Last week, I presented a poster at the National Physicians Alliance 6th Annual Meeting (pdf).  My poster discussed uses of social media in social activism, and included a review of how to use Twitter for chats and other conversations.

I am posting it below for your review.  If you have any comments, questions, etc please chime in.

Data has shown that the majority of patients want to be active in their health. Shared Decision Making (SDM) is a proven tool to engage a broad cross section of patients to actively participating in their health care. An added benefit of SDM is that it can engage people with low health literacy and disadvantaged groups. These groups defer to the physician and have poorer outcomes. Physicians engaging in SDM (shared learning) motivate underserved patient populations to become active in their health care. SDM improves outcomes for all patients who are active in their health care.

Shared decision making (SDM) is when patients and physicians work together to select tests, treatment, disease management, and support all based on evidence and the patient’s informed preferences. Shared decision making embraces the patient’s right to make decisions about their care. Both parties commit to sharing information and decision-making responsibilities. It sounds surprisingly like the ePatients, SM, and the Twitter #hcsm chat on Sunday night. Informed patients who are part of the health care process with their physician have better outcomes.

The physician directing the patient to social media is giving tacit approval for the patient to be actively engaged in their health care. Patient and physician are partners in learning. Social media is one tactic in the uptake of knowledge and resides on a larger continuum of learning. Both SDM and SM are part of a learning strategy that have a great deal in common.

When the SM discussion takes place, the physician and patient are engaging in knowledge and learning to improve outcomes. We can assume the patient is either familiar with social media or not. If patients are familiar with SM, we can assume they are active in managing and learning about their health care beyond social media. If they are not familiar with or participate in social media, they may or may not be active in learning about their health. For purposes of this essay, I will assume they are not. This as a binary model looks like the following:

Physician: 0: Wants a patient knowledge partner
1: Wants a less active patient knowledge partner

Patient: 0: Is a knowledge seeker
1: Is not a knowledge seeker wants to be lead

The 0 physician and the 0 patient are a great match because they work together in managing health care. The 1 physician and the 1 patient are also a good match, because they reside in the same space: physician leads, patient follows. Can the 0 physician motivate the 1 patient to become a 0 patient. Will the 1 physician demotivate the 0 patient?

SDM has been well studied and is primarily used in chronic and terminal illnesses or making choices between surgical or medical treatment. The UK is currently examining mandating SDM within the NHS. A study titled “Making Shared Decision-Making a Reality” ‘No decision about me without me’ by Angela Coulter and Alf Collins examines SDM in great detail. http://tiny.cc/0x59e

From that study, Table 1 presents what I see as the bridge between SDM and the ePatients, SM, physician, etc.

A key principle in adult learning is sharing of experiences (expertise) between adults, which create reflection that may become action (change in behavior, new knowledge, etc.). Physicians as noted above have extensive experience/expertise, which they apply to patient management. When patients’ own expertise/experiences are added to the physician’s, new knowledge is created which changes patient management and improves care and treatment.

SDM is a well structured and managed process relying on patient decision aids and tools to help patients understand and participate. Knowledge and information used by the patient to make decisions is provided by the HCP. It is part of the SDM contract. In SM the patient is a self-learner. They seek knowledge from others and other sources. The physician approving or pointing the patient toward SM and learning is performing a less structured more open ended SDM. The question now becomes, if SDM works and improves outcomes and benefits patients, how can we apply and frame those SDM principles along with adult learning to the SM discussion? Can we improve the health care relationship between physician 0 and patient 0? How can physician 0 motivate patient 1 to become an active participant in their health care?

There are some simple steps the physician can do prior to pointing patients to social media:

• Have the patient fill out a short form asking about their knowledge of their disease, confidence in that knowledge, what is their primary source of information, etc.
• What problems specific to their disease/visit do they want to solve?
• If they have done research or participated in social media what did they learn that changed their opinion about their disease?

This short simple exercise prior to the exam yields a great deal of information that incorporates the patient’s experiences/expertise with the physicians’ own perspective to create a new set of knowledge. With this understanding the physician can proceed with the examination and begin to help patients better articulate their problems/needs. In addition, the physician can better guide the patient in their learning moving clinical management closer to the evidence because they are both basing care on shared knowledge and trust. In the end, determining what the patient knows, what are their experiences, and how have they incorporated that knowledge will improve management and outcomes. This information is as critical as the physical exam. It should be part of the patient chart and updated at each visit. Besides tracking physical progress, the physician can track knowledge progress and compare the two.

Pointing patients to social media in and of itself is not a stand-alone activity that yields the greatest benefit. Framing the discussion of SM with an understanding of the patients’ current knowledge base and problems they are seeking solutions for will go a long way to improve outcomes and care. SDM is proven model that can be applied as stand-alone or its principles adapted to physician patient learning. In either case SM alone is only part of the solution to improving health care and outcomes.

This process may take more time upfront but, data demonstrates it yields better outcomes and in the long term saves time and cost. Framing social media recommendations within the larger context of a patient needs assessment is a better model.

During the Twitter chat mentioned above, some individuals thought the FDA’s action was intrusive and would stifle innovation. Given the potential for economic benefit in the growing health care field, I doubt this concern holds too much water. The fundamental issue at play here is if the app itself is a medical device. In section IV of the draft guidance concerning the rule’s scope, the FDA states that this concerns mobile medical devices defined as those app which:

• are used as an accessory to a regulated medical device; or
• transform a mobile platform into a regulated medical device

This was also affirmed by the FDA during its July 19, 2011 Twitter chat on its new draft guidance:

The FDA goes on to say what its rule does NOT cover. I am paraphrasing below, but if you read the scope itself , it provides good examples in defining these exclusions: 

1. apps that are copies of medical books, texts, or teaching aids (e.g. Physician’s Desk Reference or flash cards)
2. apps that only log, record, offer evaluations or suggestions on “maintaining general health or wellness”
3. apps that automate general office operations (billing, inventory, appoitments, insurance transactions, etc.)
4. apps that are general tools and NOT marketed for a particular medical condition (e.g. an audio recording or note taking pad)
5. apps that serve as electronic health records or a personal health record system

 A lot of the hubbub during the Twitter chat concerned stifling innovation in this burgeoning space. However, what many in the group did not recognize is that we already rely on the FDA to regulate medical devices, so as technology changes and encompasses apps, so too must the FDA’s purview of these tools.  A cursory look at some apps makes the FDA’s interest valid:

Smartheart: This is being represented by the manufacturer (SHL Telemedicine) as a self-service heart monitor, and as the smallest ECG. It operates by performing an electrocardiogram and allows the user to send the reading to his doctor.

IBG Star Monitor App: This involves an iPhone, an attachable iBGStar device, and the iBGSTar Monitor App. When used in concert together, the system allows patients to test their blood sugar wherever they are, record notes and send the data to their doctors.

Fujifilm Synpase Mobility: This app allows doctors to view radiology films in 2D, 3D and to use MIP/MPR as in a clinical setting from Androids, iPhones, and iPads.

Reliance on any of these tools to diagnose or treat patients makes them clearly medical devices, and well within FDA’s control.  What is still up in the air are those “wellness” apps that happen to encroach into the clinical space and are used to diagnose and treat patients. I posed that question during the FDA’s July 19th chat on Twitter concerning their new draft guidance:

I’m still waiting. And therein lies the ambiguity that will beset developers as they race to market. Will they have to submit their apps for approval as a medical device? For the wellness apps that could be used as clinical instruments, the guidelines might not be precise enough. In the example I was thinking of I imagined a pedometer as part of an obesity treatment (exercise aid) or as part of an obesity clinical study where exercise logging was a requirement or an outcome. Plus there’s the issue of the long slogging process of device approval, involving clinical trials. Granted the process is important to ensure safety, but I openly wondered if a shorter path is possible.

I am still waiting on that too. While the FDA sorts all this out, you are invited to offer your remarks at the FDA’s website where it is gathering public comments. Join in to get the last word. By the way, the docket number for this is FDA-2011-D-0530-0002 and at Regulations.gov you can enter your comments electronically.

The post will be going up in two parts.  The first post can be found here, and the second part can be read here.

I hope you will take the time to read it, and comment here (or there).