Pharma Reform

The internet and it’s applications like Twitter have created a seemingly endless source of timely information.   Sorting through the noise however to get to tweets that can help and get you the information you really need can be a real challenge.  This is especially true in the world of pharmaceuticals, biotechnology, and healthcare.   In a previous post I listed my top 10 internet sources but only mentioned a couple of helpful Tweeters.   While I follow only a small number and I’m sure there are plenty of other good tweeters,  those who seem to have consistently delivered content or links that have been helpful in keeping me current include (no particular order):

@ChristianeTrue

@kevinmd

@matthewherper

@Pharmalot

@Pharmaceutical

@cafepharma

Who do you follow that is really helpful in keeping you current?  mike@pharmareform.com

When I first read through the 65 performance metrics outlined in the ACO draft proposal from CMS (Table 1, pages 174-194) it was easy to imagine how drug treatment could help healthcare providers in an ACO meet or exceed some of their performance expectations.  Based on studies that have already been done, including regulatory clinical trials, it is clear that making sure patients are getting the right drug, in the right dose with supportive patient education and adherence programs could have a dramatic impact on improving clinical outcomes while reducing overall healthcare costs.  But pharmaceutical marketers will want to look beyond just matching and aligning their products’ regulatory claims with these performance metrics to find the hidden opportunities to deliver maximum value and patient benefits.

Healthcare failure statistics (e.g., hospital related infections, treated but uncontrolled diseases, lack of responsiveness to treatment, complications of multi-drug treatment, and patient non-adherence to treatment) while disconcerting, have often been ignored or just taken for granted.  But, these types of numbers can give clues as to where prescription drug treatment could help healthcare providers in ACOs (or other healthcare provider systems) improve the quality of care and clinical outcomes in cost effective ways.

Across healthcare, the list of failure statistics seems never ending from clinically inappropriate drugs or dosing being prescribed to adherence related issues, outright medication errors, and patient disappointment with the explanation about discharge medications.  Even a cursory internet search of product relevant disease states will yield a wealth of failure statistics that could potentially be improved, many simply with the appropriate use of  prescription drugs.

Don’t be discouraged by the variability of the statistics for any given problem.  The precision of specific numbers is not important because at this stage you are looking for clues for where you might be able to make an improvement.  You’ll get real world hard numbers from the healthcare provider sites you work with to develop your baseline data.

You should be able to put together a disease and treatment statistical profile for each of your products.  What I am suggesting is going beyond the global numbers of patients and market shares traditionally used for determining opportunities and driving forecasts.  You need to dig deeper to find the performance improvement opportunities, the types of patients or situations that represent less than satisfactory healthcare performance.   Here are a couple of examples:

Hypertension:

There are plenty of safe and effective prescription drug treatments available, including generic drugs.  When you take a quick look at the overall average numbers there might not seem to be much of an opportunity for significant performance improvement.  After all, 68% of adult hypertensive patients are being treated with anti-hypertensives and 64% are achieving blood pressures less than 140/90mm Hg (controlled).   But a closer look reveals that the percentage of treated patients is much low in younger patients (age 18-59), especially men (47%) and Mexican Americans (50%).  The percentage of controlled hypertension is also lower in older patients (58%) than in younger patients (72%), in general.  Insurance coverage has also been identified as a factor with 71% of uninsured hypertensive non-elderly adults uncontrolled.  More striking is that 52% of those with private and 45% with public insurance remain uncontrolled.

Pneumonia:

Again, at first glance one might find it hard to suggest there is an opportunity for performance improvement when you read that over 60% of elderly patients receive pneumococcal vaccine.  But a closer look reveals that the percentage of adults aged 65 years and over who had ever received a pneumococcal vaccination was 39.8% for Hispanic persons, 64.9% for non-Hispanic white persons, and 44.5% for non-Hispanic black persons.  More importantly, despite vaccinations and effective antibiotics there are still 52,000 deaths related to pneumonia in the US every year.

Depression:

While there may be considerable opportunities realized by encouraging more patients with signs and symptoms of depression to seek treatment, here are some statistics that would suggest there are even opportunities within the treated patient population.  Only 24% of depression patients recover following 16 weeks of drug or psychotherapy and remained well during 18 months of follow-up and  50% of depressed patients treated by medication relapse within two-years.

My intent here was not to provide an exhaustive statistical profile for these diseases but rather to demonstrate that previously ignored or taken for granted healthcare failure statistics, especially those related to treatment  failure may represent new ways to help healthcare providers achieve their quality and clinical outcome performance metrics.  It may take some investigation into the reasons behind some of these numbers but if they are patient selection, dosing, or adherence related, you could be onto something.

Developing a useful value proposition and supportive data will require identifying the specific failure-based  statistic opportunities and then determining with provider systems which improvements will make a difference for them and what data could be developed to demonstrate meaningful improvements.  Keep in mind, healthcare provider systems will now have electronic medical records to help track and follow interventions (e.g., education and adherence programs) and patient responses to treatment.

Again, this goes beyond marketing your regulatory claims for safety and efficacy.  It also takes some research beyond traditional market profiling in a marketing plan.  It will require creativity to interpret the ACO performance metrics in the context of how your products will be assessed and how your product might be able to improve some of the relevant healthcare failure statistics.  These healthcare system improvements in quality or clinical outcome performance metrics not only benefit patients but could have significant financial implications for healthcare providers.  mike@pharmareform.com

In the previous post we discussed the CMS proposed ACO concept for developing healthcare provider systems that engage individual healthcare providers with “shared savings” incentives to improve the quality of care delivery and clinical outcomes as defined by 65 performance metrics.

Some pharmaceutical industry executives, healthcare providers, and even patients may view these performance metrics as a biased, bureaucratic process for defining medical practice and imposing the “cheapest, least expensive” treatment options.

Whether or not the ACO concept survives in its current form is not important, but rather, I believe it represents the next level of managing healthcare delivery that can not be ignored.   I believe the draft ACO concept also represents an important new context for how pharmaceutical companies need to be looking at developing, marketing, and selling their prescription drugs.  Here’s why…

For decades the pharmaceutical industry has boasted about cost savings, cost-effectiveness, and the pharmacoeconomic value of prescription drug treatment.  Professing that prescription drugs can reduce overall healthcare costs by avoiding the ancillary costs associated with chronic diseases, reducing office visits, keeping people out of the hospital, and most importantly, preventing and curing diseases.  And despite the industry’s best efforts, these claims and propositions have seemed to nebulous, lacking in credible data, and therefore mostly fell on deaf ears within traditional healthcare provider systems.

In an ACO-type healthcare delivery system, these value propositions have real meaning, especially as they relate to the defined performance metrics.  With electronic medical records, insurers, payors, and providers will now have more robust information systems to track and report performance of prescription drugs and validate the value propositions in their own healthcare system.  That means marketing and research must be aware of how their products will now be assessed against these performance metrics and design clinical trials that go well beyond establishing regulatory claims for efficacy and safety.

Getting your product identified as a “treatment of choice” in a performance metric would be the ideal and almost assure commercial success for a prescription drug in that healthcare system.  In fact, pharmaceutical companies who align their products and deliver data driven proof for improving healthcare delivery performance metrics as defined by ACOs will find healthcare provider systems more than willing to encourage the use of their products over other, less performance impacting therapeutic options.  Rather than trying to find ways to limit the use of seemingly expensive new products, this new perspective provides rationale for healthcare provider systems to proactively promote the use of prescription drugs that can help them meet or exceed their performance goals in a cost-effective way.

In the next post we’ll explore how healthcare statistics can provide an interesting platform for driving prescription drugs in this new performance metric, ACO-type healthcare provider market.   mike@pharmareform.com

The Patient Protection and Affordable Care Act has prompted CMS (Centers for Medicare and Medicaid Services) in the US to draft a proposal for establishing Accountable Care Organizations (ACO’s).  This draft proposal outlines a concept for enrolling patients into healthcare provider systems (local networks of hospitals, physicians, laboratories, etc) to coordinate a continuum of care to keep patients healthy and to better manage their diseases for improved clinical outcomes at lower cost.

Included in this proposal are 65 performance metrics (Table 1, pages 174-194); specific quality and clinical outcome measures of care delivery.  Healthcare providers in an ACO will be required to track, record, and report their performance against these metrics to qualify for what’s called “Shared Savings” …  financial rewards … or essentially bonuses for meeting or exceeding these performance metrics, but they’ll also be subject to financial penalties for delivering expensive care or under-performance against these metrics.

What kinds of metrics are we talking about?

Well … some are more general … like the use of survey results to capture for example;

• The  level of satisfaction with physician – patient communications
• patient feedback about their provider experiences
• And whether or not the healthcare system has best practice processes in place like patient education, the extent of electronic medical records, and the use of e-prescibing

Other performance metrics are clinically oriented and much more quantitative, for example;

• The number of readmissions following hospitalization
• Healthcare acquired conditions (e.g., surgical or catheter related infections, pressure ulcers)
• The percentage of patients vaccinated or being treated with specifically identified treatments of choice ( e.g., beta-blockers, ACE- inhibitors, or ARB therapy for heart failure patients with Left Ventricular Systolic Dysfunction, warfarin for patients with atrial fibrillation)
• or the percentage of patients controlling their hypertension, blood glucose if they’re diabetics, or controlling their cholesterol levels

The ACO performance metrics go well beyond the tracking and reporting requirements hospitals now capture in their quality systems.   More importantly, these performance metrics are more likely to get the attention of healthcare system administrators and individual healthcare providers because they will be held financially accountable for delivering against these metrics.

While there is considerable debate about, and even resistance to,  the details of the draft proposal and uncertainty as to whether or not CMS can actually implement the ACO concept, this should not create a “wait and see” mentality for pharmaceutical marketing and sales.  The ACO draft proposal should be viewed as a feasible strawman proposal which will foster pilot programs at a few healthcare provider systems and will certainly elicit commentary and alternative proposals as to how to hold healthcare providers accountable for delivering higher quality care at lower cost.

In an earlier post we discussed the pharmaceutical sales and marketing challenges created by the complexity of ACO organizational structures and decision making processes. In our next post we’ll explore how this ACO concept and the 65 performance metrics could actually provide a platform to help drive revenues for pharmaceutical companies in this evolving new healthcare market.   mike@pharmareform.com

The Journal of Medical Marketing (January 2011) has published an extensive (2+ pages), informative review of Pharmaplasia™, which is now available online.   The author concludes his review :

“As I closed the book for a second time, I felt like I’d had a friendly and useful conversation with an eloquent, intelligent and very experienced man who cared about pharma and had some useful things to say.  I’d have been mistaken to expect his book to give all the answers to the challenges faced by the industry, but if I’d hoped for a more modest but still worthwhile contribution to a complex debate, I’d have felt my time reading the book to be well spent.”

Brian D. Smith   Journal of Medical Marketing (2011) 11, 90 – 92. doi: 10.1057/jmm.2010.33

The Journal of Medical Marketing currently has a free trial so you can freely view the pdf file.

mike@pharmareform.com

The increasingly influential role of clinical pharmacists in the evolving new healthcare market represents an opportunity for pharmaceutical marketers.   At the same time, to take advantage of this opportunity, pharmaceutical marketers will need to redesign their commercialization strategies and tactics.  Clinical pharmacists are not going to be receptive to traditional marketing and sales tactics.

Pharmaceutical marketers who lack sophistication and try to merely enroll clinical pharmacists as their sales advocates will be woefully disappointed.  Clinical pharmacists are well educated, well informed, and very analytical when it comes to evaluating therapeutic treatment options.  They have an insatiable need for clinical data to support not only efficacy and safety but also the value proposition for a product.

Pharmaceutical marketers should spend some time understanding the different roles clinical pharmacists might play in the evolving healthcare system and better determine the information needs and evaluation criteria used for assessing products in therapeutic categories that pertain to their marketed products.  More importantly, pharmaceutical marketers should understand the best ways for packaging and presenting their product information so as to assist clinical pharmacists with their product evaluations, presentations, and fulfilling their clinical responsibilities.

Assuming you have a high demand product that fills a significant unmet medical need, clinical pharmacists can play a critical role in making sure your product is available in their healthcare system, is a part of treatment guidelines and highlighted in any e-prescribing support systems they use to encourage appropriate use.  They can facilitate educational programs for physicians and patients to ensure that the right patients are considered for your product, are aware of any potential safety issues, and reinforce the value of your product relative to other therapeutic options.  Clinical pharmacists are also well qualified to be clinical care coordinators in Accountable Care Organizations, and are organizationally well positioned to ensure patient compliance and adherence while monitoring and tracking the financial benefits derived from appropriate use of the product.

So tactically, what does this mean for pharmaceutical marketers?  Here are some things to consider.  Who will be making your product presentations to ensure product inclusion on formularies and securing reimbursement?  Do they have the credibility and training necessary to discuss the clinical data and value proposition (e.g., outcomes and quality metric implications) without having to refer questions to the company Medical Affairs department?  Do you have a user-friendly, comprehensive product dossiers with any efficacy, safety, or value claims (including outcomes and quality metric implications) supported by published clinical data?  Can you provide clinical trial designs and templates for doing comparative efficacy trials for your product?   Can you customized your healthcare provider and patient education materials  for specific healthcare systems?  Are you ready with electronic medical records integration technology and patient care support apps for mobile devices (think e-prescribing and adherence support)?  Can you help with customized electronic models for tracking and analyzing improvement in outcomes and quality metrics consistent with the healthcare provider system goals and objectives?

Reception of these tactics will depend on the healthcare provider system and the clinical pharmacists but also the quality and value of the products and tactics being made available.  The key is for pharmaceutical marketing to align with and embrace the needs of clinical pharmacists and find ways to help healthcare provider systems accomplish their goals and objectives in this evolving new healthcare market.  Pharmaceutical marketers who figure this out can create a significant competitive advantage and enhance revenue growth, assuming they have the innovative products, the data to support their claims, and tactics that are supportive and embraced by healthcare provider systems.

mike@pharmareform.com

The clinical pharmacist has gradually evolved in influence from the early 1980’s to a new point of power with healthcare reform, especially in anticipation of Accountable Care Organizations.  While some may have an extended clinical role out of their community pharmacy (e.g., nursing home services), I’m not talking about the dispensing pharmacist behind the counter at your local pharmacy.  I’m talking about the highly trained drug treatment specialists with extensive clinical experience who now play an even more influential role in the increasingly managed healthcare delivery system.

I’m talking about the clinical pharmacists who evaluate and make formulary recommendations for treatment options within large healthcare systems, managed care, Pharmacy Benefits Managers, government agencies (think CMS), and at healthcare insurance companies.  I’m talking about clinical pharmacists who are rounding in the hospital with attending physicians; monitoring, evaluating, and consulting on drug treatment. And, I’m talking about clinical pharmacists who are delivering and managing chemotherapy and other intravenous drug treatments in the outpatient or home health settings.

Clinical Pharmacy’s power comes from the ability to influence formularies and reimbursement decisions, draft treatment guidelines, and recommend treatment choices.  They are frequently involved in clinical trials and may find themselves increasingly involved in designing, executing, and evaluating “comparative effectiveness” studies.

More importantly, clinical pharmacists could be in the best position of healthcare providers to monitor and manage patient compliance and adherence to treatment, ensuring that treatment outcomes and quality metrics improve, and patients realize the full benefit of drug treatment after the prescription has been written.

The intensifying cost consciousness of the managed healthcare market being driven by healthcare reform and the opportunity for financial incentives from Accountable Care Organizations will further elevate the relevance, importance, and value of the drug treatment expertise of the clinical pharmacist.

It is important for pharmaceutical marketers to understand and appreciate the increasingly influential role of the clinical pharmacist in the evolving new healthcare market.  See why in the next post.  mike@pharmareform.com

This may sound simplistic and obvious.  But, have you noticed lately that pharmaceutical companies appear to be struggling with a confusing array of seemingly contradictory strategic choices?  Some of these choices leave even the most knowledgeable industry followers wondering and speculating about the rationale behind the decisions.

Should they get bigger, should they downsize?  Should they acquire, grow organically, or divest? Should they be “pure” pharmaceutical plays or diversified healthcare companies?  Should they continue to exploit the US market or expand into emerging markets?  Should they rebuild and restructure R & D or move to a more flexible outsourcing model?  Should they focus on diseases, products, or technologies?  Are regulatory compliance, manufacturing quality, and integrity important for building trust and credibility or are they “envelops to be pushed” for competitive advantage and financial gain?  Strategic and tactical choices that can affect business today and well into the future.

So what’s the big deal?  Don’t all companies go through this?  Why is this important?

It’s important because, when a company determines who they are, finds its purpose, and develops a passion for what they do; strategic and daily operational decision making become easier and are more likely to deliver the organizational goals and objectives that support the company purpose.  This corporate understanding of “self” includes a deep seated set of behavioral expectations, values, and principles by which the company operates and does business.

Definition, consistency of behavior, and organizational alignment allow employees to embrace and support the corporate purpose in their daily activities.  Decisions become easier as choices and options either fit or don’t fit the behavioral values or purpose.  More importantly, employees, prospective employees, customers, collaborators, and investors all know what to expect from the company.

Despite all the mission and vision statements in their lobbies, I believe many of the Big Pharma companies today have lost their purpose and are confused about their ”self.”  With a fixation on near-term financial performance (their apparent purpose), they seem to be struggling to find the “quick fixes” to business success in the evolving new healthcare market.

Most pharmaceutical companies would never admit they have lost their purpose.  At the same time, if they were to explore this fundamental business principle, many might learn that even their management teams are uncertain, if not finding total organizational disagreement about who they are and what they do.

mike@pharmareform.com

Over 70% of prescriptions today are filled with generic drugs.  Once a branded product loses patent protection, they experience generic erosion and a rapid decline in market share of prescriptions.  With the healthcare market becoming increasingly more managed (think government, insurers, and Pharmacy Benefits Managers) and the dramatic difference in price (generic drugs being significantly less expensive) it doesn’t take long for generic drugs to replace branded products in the market.

But …  what would happen if the branded product manufacturers (Big Pharma) started to “match generic drug prices” once their product patents expired?   As generic drugs of the branded product come to market, the branded product matches their price or even prices slightly lower than the generic drug to preserve their market share.    Surely, nobody could be a lower cost manufacturer than the innovator, brand manufacturer.

Let’s think about this. The branded company development costs are well behind them.  Manufacturing facilities, equipment, and staff are already in place.  Training, quality systems, and regulatory compliance requirements are also in place.  Operational efficiencies have been honed over years of production.  Branded manufacturers can certainly negotiate at least as good a terms on API (active pharmaceutical ingredients), packaging, and supplies as the generic drug companies.  And while branded manufacturers may have higher “overhead expenses” that’s an accounting allocation issue.  Building a patient base, marketing, sales, and supply chain logistics are already in place for the branded product.

The generic drug company on the other hand has to develop the generic product (formulation and establishing bioequivalence can be challenging), purchase and set up manufacturing capabilities (or retool what they have), source API, packaging, and supplies, put in place new manufacturing SOPs (standard operating procedures) and regulatory required quality processes.  They have to hire and train new personnel (or at least retrain current staff), develop their regulatory filing, and secure FDA approval.  They may even have to challenge the patent validity of the innovator product.  And once approved, they have to market to and negotiate with the supply chain and the managed market.  In the end, these are all new costs for generic drug companies that have to be covered in the price of their new product entry.

In the past, branded products matching generic drug prices would have meant leaving money on the table and forfeiting profits as generic drugs gradually made their way into the market over a period of years.  Today, however, it only takes a matter of months before a majority of branded prescriptions drugs can be converted to generics.

I’m sure somebody has already done the math on this from a Big Pharma profitability perspective but I still believe that “matching generic drug prices” could have value for patients and Big Pharma.   Matching generic drug prices would preserve a large patient base of lifetime revenue (albeit at lower margins) for the branded product.  It also rewards loyal patients with lower prices for the same drugs they may have been taking for years. It would certainly make it easier and more efficient for healthcare providers, patients, and the managed market in that there would be no reason to worry about changing patient prescriptions.   And, while Big Pharma might view this as “throwing in the towel” ,  this approach would be a challenging “game changer” for the generic drug industry.  mike@pharmareform.com

As mentioned in the previous post generic drugs now account for more than 70% of prescriptions filled in the US and that percentage is likely to increase with patent protection expiring on several blockbuster products over the next 3-5 years.  With additional support from the Obama administration to exploit the potential cost savings from the use of more generic drugs and continued efforts to ease the way to market for generic drugs, including biologics, you would think the future for generic drugs has never looked more promising.  Yet, there are five vulnerabilities and risks that could undermine the cost savings potential and success of generic drug manufacturers in the future.

• Manufacturing Quality

Drug manufacturing is difficult, especially delivering lot-to-lot consistency for tablets and capsules and ensuring the sterility of injectable products.  One of the biggest concerns raised most often about the use of generic drugs is whether they are, in fact, the same as the branded products.  The FDA goes to great lengths to dispel purported generic drug misinformation and to provide definitive answers to common questions regarding comparability.  According to the FDA website:

“Health care professionals and consumers can be assured that FDA approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.”

I’m not sure how the FDA can possibly making sure “all generic drugs have the same high quality, strength, purity and stability as brand-name drugs.”  When you consider the increasing number of generic drug products being made available by more manufacturers (many, if not most, not even in this country), their assurance seems a bit definitive and even suspect (lacking credibility) given FDA’s already stretched resources and limited inspection capacity and capabilities.

Generic drug vulnerability in manufacturing quality comes with the potential for some well publicized cases of documented manufacturing problems, safety issues, or FDA warnings about any quality concerns that would compromise healthcare provider and public confidence in the efficacy or safety of generic drugs.  In fact, any concerns voiced by the FDA with regards to the use of generic drugs could destroy the confidence of an already skeptical patient population.

• Unsustainable low prices

Even though generic drug manufacturers have built their business models around being low cost providers they still must make a reasonable profit to stay in business.  It is important to note that drug manufacturing, especially sterile injectable drugs, is not cheap.  Regulatory compliance and cost of goods can still make pharmaceutical manufacturing expensive, even for generic drugs.

When the healthcare market (e.g., pharmacies, wholesalers, Pharmacy Benefits Managers) drives competitive prices down to a point where even generic drug manufacturers can no longer make a reasonable profit, fewer manufacturers participate in that market and ultimately the healthcare market becomes more susceptible to shortages for those products.  I believe this is a major reason for the current shortage of over 150 medically necessary drugs, many which are generic drugs.

So, generic drug manufacturers are vulnerable to the negative financial impact of unsustainable low prices.  When they decide to manage this by limiting or eliminating the manufacturing of low or no margin products they leave themselves open to criticism and diminished public confidence as more of the critical drug shortages start to be blamed on the generic drug industry rather than on Big Pharma (the perception today).

• Supply of Active Pharmaceutical Ingredients (APIs)

As generic drug manufacturers squeeze their suppliers for lower prices, those suppliers also lose interest in delivering at those low prices and a cascade of events begins to drive a shortage of APIs when you need them.  Without the financial incentives (reasonable profits) to ensure supply availability, even API suppliers start to limit and maybe even discontinue making the lowest margin products on a regular basis in favor of higher margin opportunities.

Unlike in other markets, the regulatory and manufacturing challenges of pharmaceuticals makes it difficult and time consuming for new manufacturers (API or generic drugs) to step in and take advantage of these drug shortages.  Even if a new manufacturer were able to begin production, the finished generic drug’s price would almost certainly be much higher than the previous generic drug price.  Again, potentially irritating and alienating the healthcare market and patients.

• Burdensome Government fees

Additional fees levied on generic drug manufacturers (i.e., FDA reviews) as proposed by the Obama administration could erode the cost savings potential to the healthcare providers system.  Expecting generic drug companies to absorb these incremental fees could be counter productive (resulting in higher generic drug prices). More importantly, high fees across a portfolio of products could put sustainable profitability for smaller  generic drug companies at risk, even forcing some out of the market.

• Product Liability

As more products become available and more patients take generic drugs, product liability cases will inevitably increase for generic drug companies.  As a result, they may become more inclined to avoid or quit manufacturing products with the potential for an inordinate amount of litigation.  Again, with their low cost of operations and thin profit margin business models, repeated and protracted litigation for low margin products may not be financially feasible, will add to their overall cost base, and could negatively impact healthcare provider and patient perceptions of quality.

The potential liabilities for generic drug companies is especially noteworthy in light of the pending Supreme court review of whether or not generic drug companies can be held liable for “failure-to-warn” when they rely on the prescribing information developed by the branded drug company and approved by the FDA.   Should generic drug companies not prevail, it will open generic drug manufacturers to new potential liabilities and future litigation which could further compromise their low cost business models.

So, while the future looks very promising for generic drug manufacturers, it is not without challenge or risk.  For the market to continue to reap the financial benefits of a consistent and safe generic drug supply, generic drug manufacturers must guard against these vulnerabilities.  And as much as insurers and patients might enjoy the low prices we pay for generic drugs, the low prices only matter when the products are as effective as the brand, are safe to take, and are available when we need them.

mike@pharmareform.com