Why a Six Sigma Based Quality System May be the Answer for Pharmaceutical Companies

Life science companies experience no lack of quality system ideas, quality system conversation, quality system arguments, quality system implementation methods, etc.

After all, even the required systems of quality management such as the FDA’s GMP, GCP and GLP regulations and guidelines are specified to a certain extent but still don’t determine all of the whens, hows, whys and whats of in-house quality system management. As a result, life science companies are left with a few decisions to make:

1) On what system(s) should a quality system be based?

2) How will the quality system’s data be managed?

3) How will the quality system’s documentation be managed?

4) What will be the KPIs (key performance indicators) of the quality system?

5) How will a need for improvement be justified?

Note: The first of these questions will be the focus of this article although questions #2 and #3 will also be discussed as auxiliaries to discussion regarding #1.

What Quality System is the Right Quality System?

First of all, it is essential for life science companies to realize that every quality system is nothing more than stated limits of discipline and a successful quality system is made of stated limits of discipline that are followed. Those stated limits of discipline however must originate from a specific mentality or template for a “starter quality system.” The quality system that a life science company selects will of course continue to evolve but upon the initiation of a new or revised quality system it is important to choose the “quality system mentality” best suited to any given company. This can be difficult.

After all, some say lean manufacturing must be adhered to; others vouch for PAT and still others Six Sigma. Some say a combination of these systems work best and all of them are probably (at best) only partially right. So, how will pharmaceutical companies make the best decision for the unique needs of their own company?Could Six Sigma be the right starter quality system?

This article posits the idea that as a starter quality system, Six Sigma is ideal for the pharmaceutical industry. This position does not exclude lean manufacturing or PAT systems of management, but instead recommends Six Sigma as the initial system of practice. Why? For starters, Six Sigma ideals are based on intense statistical analysis and serious data collection, and the pharmaceutical industry just happens to have colossal amounts of data and documentation. This data and documentation, with the appropriate amount of time, could be analyzed according to Six Sigma methods and then used to adjust less-than-stellar aspects of the quality system. The Six Sigma system also focuses on the near obliteration of deviation or nonconformance events which for pharmaceutical companies falls exactly into line with regulatory standards and quality management goals.Easier Said Than Done

Any reader may easily volley this article’s position by stating that Six Sigma is difficult to implement and that most pharmaceutical companies don’t want to change anyways. According to an online source1 however the benefits of making the right changes within the very wealthy pharmaceutical industry are staggering. The online article states that “the potential worldwide cost savings from efficiency improvement could be as high as $90 billion.” This article still acknowledges however that the reader is correct in saying that Six Sigma is difficult to implement; Six Sigma implementation requires know-how and the appropriate instrumentation. That know-how and instrumentation will vary greatly since it is likely that a very small percentage of Six Sigma black belts would be even remotely qualified to cross the pharmaceutical threshold (an intelligent in-house manager might do well simply studying up on Six Sigma principles).

Six Sigma tools may vary as well. After all, the “Six Sigma mentality” doesn’t specify tools (the Six Sigma calculator wouldn’t necessarily even be a required purchase) but does specify the principles of data collection, analysis and a decrease in deviation. What tools can be used for the implementation of Six Sigma?

A vast variety of software solutions might be able to help provide the needed Six Sigma success but should be chosen carefully. For most pharmaceutical companies it seems likely that management tools/software for data collection (data and document management software) and tools for any type of deviations or nonconformance management could be valuable. Since small amounts of deviation usually depend on the speed of information distribution within a company (although even that assumption could be subjected to Six Sigma analysis), an automated training solution triggered by changes in SOPs, work instructions, etc. might also be of great value.Conclusion

Essentially the keys of Six Sigma are rigorous data collection, analysis and a decrease in deviation, principles which would seem to attract the naturally rigorous pharmaceutical industry.

1 http://www.contractpharma.com/articles/2007/10/lean-practices-in-a-life-sciences-organization

Powered By Rxid.com

Tags: Fda, Gcp, Glp, Gmp, Lean Manufacturing, Life Science Companies, Pharmaceutical, quality system, Six Sigma, Six Sigma Tools
Posted in Pharmaceutical | 2 Comments »

5 Reasons Medical Device Companies Should Automate Their Quality Systems

Medical device companies manage their respective quality systems not with the goal of “staying busy” but with the ideal of producing high-quality, innovative products that don’t jettison a trail of product recalls and process deviations along the way. Every medical device designer, manufacturer or quality control representative would likely agree that medical device companies should standardize a process that gives birth to high quality products and simultaneously attacks every deviation, nonconformance or customer complaint with the speed and vigor of Spartan warriors.

Simple enough?

It would seem so but even with all the combined brain talent of designers, manufacturers and quality control personnel this ideal bionic process still seems like nothing more than a medical device nirvana. In fact, current quality system management habits within most medical device companies emulate Isaac Newton’s first law by remaining “in a state of uniform motion…unless an external force is applied…”1The External Force for Medical Device Quality Systems

The external force that should be applied to most medical device quality systems is the force that is inevitably required by almost every industry. That force is technology. The right technology can help medical device companies create the streamlined and automated quality system processes that WON’T vary under any circumstances unless confirmed and logical data points to evidence-based deviations, nonconformances, customer complaints, etc.

That’s one reason for medical device companies to start automating their quality systems with the right quality system management technology. Listed below are 4 more:#2: The FDA is Moving along the Automation Pathway

Let’s face it. The FDA rules the U.S. regulatory roost and every medical device company that wants to produce or sell products in the U.S. has to conform to its quality system regulations. Conforming with FDA regulations becomes easier when FDA requirements are duly anticipated by medical device companies. For example, a recent FDA News bulletin states that, “FDA-mandated electronic Medical Device Reporting (eMDR) could happen in a soon as 18 months,” which means that medical device submissions will soon have to be submitted electronically and medical device submissions are far easier to submit electronically when they are consistently managed electronically with an automated quality system solution.#3: Decrease Quality System Breakdowns

George Bernard Shaw once said that “The problem with communication … is the illusion that it has been accomplished.”3 The illusion that information is being communicated or that employee morale is “fine” is often the sign of communication breakdown. Communication breakdowns are catalyzed by tedious paper-based routing procedures, capsulated quality processes that disconnect product lifecycles, customer complaints that never reach the investigations department, approvals that are too numerous to complete quickly, possible deviations that can’t be backed with proof, etc., etc.

Once medical device companies automate document control, information routing, approvals, quality data connections (customer complaints to CAPA investigations, etc.) and provide tracking and reporting features that help readily identify deviations and nonconformances, REAL communication suddenly engenders results—not illusions.#4: Uniting Quality Systems Across Geographic Barriers

When a medical device company begins to expand or continues to do so, automated software that is web-based becomes the pot of gold at the end of the rainbow. Web-based solutions for instance allow companies to expand on a national or global level and still stay abreast of salient information. Medical device companies (depending on their current situations) are also likely to benefit from a software provider that allows medical device companies to select from various networking options (shared licences, EFP replication, etc.).#5: Help Make Quality an Aspect of Every Department

For many medical device companies, quality system management is in the hands of the quality control team. Although this establishment of responsibility has worked in the past, quality system management now must move faster and more efficiently to meet increased demands for quality products. The truth is that much of a quality system can be managed bit by bit and employee by employee when training is automated and a quality management system (plus associated information) is available quickly for the right employees in the right departments.

Medical device companies also need to search for a training software solution that can be automatically triggered by essential document changes and that can control GLP, GCP and GMP training tasks (plus other training tasks) across a company wide spectrum.

Curt Porritt, VP of Marketing at MasterControl says the following in his article entitled Adopting Technology in the Life Science Industry: Why Is It Taking So Long? states and paraphrases the following:

“…according to Life Science Insights, an IDC company, over 60% of survey respondents cited GMP/GCP/GLP processes as the main driver for increased IT spending. In this same survey, 62% of respondents said they intended to spend more on electronic data integration tools. When asked why they intended to spend more, their main reasons (in the order cited) were: increased collaboration, regulatory compliance requirements, reduced time for one or more processes, and reduced costs for one or more processes.”5 Conclusion

Mary Collins, director of regulatory and industry relations for

Image Solutions Inc. says the following in regards to the implementation of electronic software solutions:“No matter how you get started [implementing electronic solutions], you [must] get started now. Over the next 10 years, you will see the different regions of the world come closer together and harmonize more on electronic requirements, and, to some extent, their regulatory requirements.” 4

For medical device companies, the advice remains the same. Staying connected with quality system technology will help med device companies keep pace with changing quality system standards.

________________________________________

References

1 csep10.phys.utk.edu/astr161/lect/history/newton3laws.html (Retrieved Jan. 24, 2008)

2 FDA News email (Received Jan. 24, 2008)

3 wisdomquotes.com/cat_communication.html (Retrieved Jan. 24, 2008)

4 mastercontrol.com/newsletter/feature/adopting_technology_1007.html (Retrieved Jan. 24, 2008)

5 http://209.85.173.104/search?q=cache:4Vn3H0TV2O0J:www.parexel.com/pdfs/e-solutions%2520in%2520clinical%2520trials%2520-%2520R%26D%2520Directions%25207.07.pdf+E-Solutions+in+Clinical+Trials:+Digital+Dilemma+Michael+D.+Christel+pharmalive.com&hl=en&ct=clnk&cd=1&gl=us (Retrieved Jan. 24, 2008)

Powered By Rxid.com

Tags: customer complaint, Fda, medical device companies, nonconformance, process deviations, product recalls, quality control, quality system
Posted in Medical Software | No Comments »

So Who Do You Believe? Pharmaceutical Ethics

There are various reasons why many people are skeptical about taking prescribed medications. Some believe that there are just too many chemicals in them and would prefer a more natural approach. Others feel that prescribed drugs are being used too freely. What many people have not considered though is the fact that they may be being deceived regarding the quality of the prescribed medications.

We all assume that medical research is documented and properly researched at least when it comes to inventing new drugs and treatments. After all, we have strict government regulations in place to ensure our safety. It appears that we may not be as protected as we may assume.

It has been found that a particular pharmaceutical company has been using employees to ghostwrite research material and then having the appropriate medical personnel attach their names to it thus making it appear as valid research information. Yikes! What makes it even more disturbing is that it doesn’t seem to be an isolated incident. Apparently, there are numerous claims that ghostwriting medical research is a common practice within the pharmaceutical industry.

Not only can this practice be viewed as alarming and dangerous but using another’s research is also unethical. Coming to basic facts, it is downright scary because it involves public health and safety. So far, little news press has been given to the potentially grave consequences of these practices, but the US Food and Drug Administration are now in the process of determining whether to allow the circulation of peer-reviewed journal articles to be used as guides. While in the past physicians have used these articles to determine drugs of choice for a particular patient, the FDA will look into the efficacy and safety of this practice to decide its future worth.

What needs to be taken into consideration is how much attention does the professional signing this research really give to its content? He or she could be recommending a medication that will reach the people at large and could prove not only mildly detrimental but also downright dangerous. After all, professionals are needed in medical and pharmaceutical research to prevent such an eventuality. If their research means so little, then why not dispense with it and let the ghostwriters do the research and clear the drug for open market? All of the current indicators are pointing in this direction right now. No claims can or should be made that this is happening in every pharmaceutical company as they each have individual moral and ethical standards. We the public can only hope that the companies making such prescribed drugs fall into the “good moral” category.

One good aspect is that at least this deception is being brought to light. Other pharmaceutical companies that are walking a fine line on this issue may think twice about the consequences of their actions. For all of our sakes let’s hope that they do.

Want more news on Pharmaceutical Ethics? Have a comment or question you’d like to share? Come join others at Boomer Yearbook for simple and effective coaching tips and strategies.

www.boomeryearbook.com is a social networking site connecting the Baby Boomer generation. Share your thoughts, rediscover old friends, or expand your mind with brain games provided by clinical psychologist Dr. Karen Turner. Join today to discover the many ways we are helping Boomers connect for fun and profit.

For www.boomeryearbook.com

Powered By Rxid.com

Tags: baby boomer, boomer year book, deception, Fda, pharmaceutical ethics, skeptical
Posted in Pharmaceutical | No Comments »

“me-too” Drugs: Good or Bad?

Introduction

A drug that is structurally very similar to already known drugs, with only minor differences. The term “me-too” carries a negative connotation. However, me-too products may create competition and drive prices down1.

The majority of the new products the industry puts out, are “me-too” drugs, which are almost identical to current treatments but “no better than drugs already on the market to treat the same condition.” Around 75 percent of new drugs approved by the FDA are me-too drugs. They can be less effective than current drugs, but as long as they’re more effective than a placebo, they can get the regulatory green light2.

This isn’t surprising at all, as someone who works in the field, but these so-called “me-too” drugs, which are reportedly better than their forebears, is driving costs. A “me-too” drug is a drug that has its origins in another drug. Probably the most famous example of this is Prilosec (“The Purple Pill”) and Nexium (“Today’s Purple Pill”). Prilosec’s active ingredient is omeprazole. Nexium’s active ingredient is called esomeprazole. The difference is that Nexium is the left-handed version of omeprazole. In chemistry, S stands for sinister, which means the molecular conformation has a left-handed orientation. (D would be right handed.) So this S-omeprazole is one half of the mixture that comprises its predecessor. By specifically picking only the S conformation, the drug is made more potent. This sounds great, but its efficacy is only marginally better than Prilosec-, which has a generic version, and costs about a third less than Nexium. Some other “me-too” drugs are: Claritin (loratidine) and Clarinex (desloratidine), Celexa (citalopram) and Lexapro (escitalopram)3.

What are “Me-Too” drugs?

Ever since the advent of modern chemotherapy, when drugs were discovered and developed through the process of screening thousands of molecules for a variety of disease conditions, using animal models, there has been a growing criticism that too many molecules were developed with similar chemical structure and the same pharmacological profile, with very little to distinguish them from each other in terms of their therapeutic utility. In other words, once the first breakthrough discovery is made of a new pharmacological activity for a new molecule, subsequent years saw the emergence of a host of new molecules or “me-too” drugs from the same chemical class and possessing the same pharmacological profile.

Such follow-up drugs have been termed molecular modifications, molecular roulettes or copycats, the development of which are alleged to be motivated by purely commercial considerations. They are also deemed to involve lower levels of innovation, compared to the original molecule. It is important to analyze in a historical perspective the end results of such efforts in different therapeutic areas of developing new molecular entities, as later generation products, after an initial breakthrough discovery has been made and the technical, medical and commercial merits of developing such drugs.

Development of “Me-Too” drugs

The success rate in the discovery of new chemical entities with fundamentally new chemical and biological profiles of activity are very low. In fact, even chemical entities within the same structural class of an approved drug are becoming rare now, compared to the period of sixties to eighties. In 2001, $ 26 billion was spent on developing new drugs and the U.S. FDA approved only 9 new chemical entities. At the same time, two thirds of the drugs approved from 1989 to 2000 were modified versions of existing drugs or even identical to those, in newer forms and formulations4.

Of the 1,035 drugs approved by FDA during 1989 to 2000, only 361 or 35% contained new active ingredients. Of these, only fewer than half were granted priority review status by the FDA. One impression is that these drugs are slightly altered versions of existing drugs, with little to offer in terms of better activity or tolerance, let alone new pharmacological profiles. The implication is that such drugs are developed, as patents on top-selling original drugs run out and not many truly new medicines are discovered. The indication that many of these drugs do not offer any major advantages over existing drugs is given by FDA’s unwillingness to grant priority review for most of them.

On the other hand, conventionally, the Regulatory Agencies, including the FDA, are not obliged to consider better efficacy over existing drugs as a criterion for approval; rather, they require only the establishment of efficacy and safety of the new drug over a placebo.

How good are they?

Notwithstanding such perceptions, historically, many “me-too” drugs have proved to be considerably better than their original counterparts. Examples are a series of generations of beta-blockers, which came up after the original drug Propanalol was discovered by ICI, with most of them having merits in terms of better efficacy, cardio-selectivity and safety. Ranitidine, the first follow-up drug after the introduction of the first H-2 receptor antagonist, Cimetidine, was followed by Famotidine and in each case these “me-too” drugs had notable merits over the original drug.

Apart from the major breakthrough in the development of orally active beta lactam antibiotics of the Penicillin and Cephalosporin class, within the same oral derivatives, there have been considerable improvements brought about by change in the side chains incorporated by condensation of specific agents with 6-APA, 7-ADCA and 7-ACA. A whole new range of broad-spectrum antibiotics of these structural classes could thus be developed. In each of the major classes of antibiotics, classified according to the mechanisms of their action, namely inhibition of cell wall synthesis (Beta Lactams, Vancomycin), inhibition of bacterial protein synthesis (Erythromycin, Tetracycline, Streptomycin), inhibitors of DNA or RNA replication (Quinolones, Rifamycins), inhibition of Folate Coenzyme biosynthesis (Sulfa drugs, Trimethoprim), there have been several “me-too” drugs marketed.

An important recent example to show that ‘me-too” drugs need to be developed is the case of the oral hypoglycemic drug Troglitazone, approved as an anti-diabetic drug in 1997. The drug was withdrawn from the market following reports of unacceptable hepato-toxicity. The follow-up “me-too” drugs, Rosiglitazone and Pioglitazone are much less toxic and are today widely used. If these drugs were not developed, the withdrawal of Troglitazone would have left a major therapeutic gap in anti-diabetic therapy.

“Me-Too” drugs: Strategies for New Drug Research for Indian Companies

Breakthrough innovations in pharmaceutical industry, of new drugs, such as the first beta blocker, the first NSAID, the first of each class of Antibiotics, Calcium Channel blockers, ACE inhibitors, Sulfonyl Ureas, Biguanides, Insulin, Glitazones, Glinides, Tricyclic Anti Depressants,major and minor Traquillisers, Selective Serotonin Receptor inhibitors, H-1 and H-2 Receptor antagonists, Proton Pump inhibitors etc are relatively rare and even though a few of the original drugs under these classes are still very much in use, they have been superceded in most cases, by later generation products, many of them “me-too”. The newer drugs are discovered both through incremental innovations on the original drugs as well as through new research.

Generally the original discovery leads to feverish activity both within the innovator company as well as in Competitors’ laboratories, to develop better products in the same therapeutic category. The essential caveat for commercial success, however, is that the newly discovered molecules should meet the minimum standards of patentability. For example within three years of the discovery of the highly successful Sildinafil Citrate (Viagra), three more new versions for the same indications have been patented and developed5.

Me-too drugs also provide therapeutic advantage6. For the practicing physicians, there’s the benefit of established drug MoA with a “me-too” medication, coupled with clinical studies that – hopefully – show patient-centered benefits such as better adverse events profiles, less frequent dosing, less bothersome potential for drug/drug interactions, and so forth. A “me-too” drug is a helluva lot easier to incorporate in practice than a totally novel medication7.

“Me-Too” drugs: The hidden dynamics

The most common criticism of drug development centers on the so-called “me-too” drugs that employ the same biological mechanism as pioneer brands. This involves a lot more than such high-profile targets as the anti-ulcer drug Nexium. We should be thinking about antidepressants, cholesterol-reducing drugs, diabetes treatments, anti-psychotics, and other therapeutic categories that have seen both blockbuster sales and rapid innovation. There is quite a bit of evidence that follow-on drugs do a lot of patients a lot of good. The newer statins, for example, often out-perform the older ones in clinical trials where the endpoints are the number of heart attacks and deaths prevented.

Me-too drugs are also a powerful tool for cutting health care costs. We should be glad that our research industry does not target only brand new biological mechanisms. That would be a very expensive business model indeed. Fortunately, the industry also works on marginal improvements, exploiting opportunities to make drug therapy better and sometimes opening the door to really radical improvements that happen to lie more or less next-door, scientifically speaking. In the meantime, we get price competition as a by-product. Me-too’s almost always undercut the prices of the pioneer drugs.

Another part of the me-too story gets almost completely ignored even though it is extraordinary important. For me-too manufacturers, advancing the science is a way to gain a competitive advantage. The classic example is the statin class of cholesterol drugs. Research on one of the follow-on drugs (Pravachol) demonstrated for the first time that using a statin to reduce cholesterol would actually prevent deaths from heart attacks, something that had previously been assumed without proof. Additional trials for several statins, including Lipitor, the formidable challenger to Zocor and Pravachol, have demonstrated that serum cholesterol is far more important than almost anyone thought (for preventing strokes, for example).

There are lots of other stories about the benefits of new research from me-too drugs, but they are part of a larger story: new uses for old drugs. The data showing a slowdown in new drug approvals exclude essential information: discoveries of new uses for old drugs. This kind of discovery has become so common that it amounts to a “new-use” revolution. One of the scientific ironies of the new era of pharmaceutical research is that as drugs become more tightly targeted on biological mechanisms, their uses actually become more diverse. This is because the body typically uses specific mechanisms over and over again, sometimes in what appear to be completely unrelated ways.

Consider the SSRI antidepressants. A recent Science article on the diverse and unexpected applications of drugs that fiddle with serotonin reuptake which is what the SSRIs do concluded that the very term “antidepressant” is misleading because there is no scientific reason to think of this drug as being just for depression. Fighting depression just happened to be the first really useful condition that was explored for this very interesting class of drugs.

Another example is the Cox-2 inhibitors like Celebrex (and Vioxx, which is important in this story and may return to the market partly for this reason). These were invented to relieve arthritis pain. But the Cox-2 enzyme turns out to be important for lots of things including cancer and Alzheimer’s. Clinical trials to exploit these leads have been underway for years. Celebrex has already been approved for reducing the risk of colorectal cancer, and Vioxx has also achieved promising results. Of course, the big news recently has been that these drugs may cause heart attacks. But even here, me-too economics is of surpassing importance. The traditional NSAIDS (non-steroidal anti-inflammatory drugs) like Alleve and Advil may have the same heart attack risks. The potential risk has been there for decades, but only the new drugs-the Cox-2s-have been put through large-scale long-term clinical trials because those are the only ones still under patent. This is an example of how me-too drug development adds importantly to the research base. Thanks to the me-too’s, we are learning about NSAIDs, heart attacks, cancer and probably much more.

Also dominated by new uses are the new-targeted cancer drugs, which attack such specific biological mechanisms that they avoid killing every fast-growing cell in sight (as traditional chemotherapy tends to do).

The implications are clear. The annual count of new drug approvals will only show a tick when a new cancer drug or a new statin gets its very first approval. But a new use for an old drug can be as valuable as an entirely new drug, or even more valuable when you consider that we know more about the safety profile of old drugs and one drug will sometimes do the work of two (preventing both heart attacks and strokes, for example)8.

Me-too products can sometimes have important advantages on tolerability or dosing. It could help create more competition and lower the price. If you have five me-toos, possibly the sixth is something that is a little better. That is for the plans to decide on behalf of their patients. And even if it has the same mechanism of action, more competition could help drive down the price of the entire class. That’s an important influence, with potentially an improvement in health from greater access.

How bad are they?

Even though the major problem of antibiotic therapy, namely drug resistance cannot be addressed by the development of “me-too” drugs, due to the propensity of the same class to develop cross resistance; in most cases, the new semi-synthetic derivatives had distinct advantages over the earlier ones. Thus, for example, the first generation Cephalosporins are useful for gram-positive infections, while the second-generation drugs cover a broader spectrum including gram-negative organisms. The third generation drugs provide resistance against the beta lactamase enzyme, as well as acting against some of the most intractable infections, such as those caused by Pseudomonas and Klebsiella strains.

Even while the pharmaceutical industry turns out families of me-too drugs for relatively mild conditions in affluent people, it pays almost no attention to serious diseases, such as malaria, affecting impoverished people. It also gives short shrift to less profitable drugs, so there now are shortages of some vaccines and life-saving drugs9.

The big problem with me-too drugs is that they are chemically very similar to other drugs already available, yet they are marketed as if they were important new breakthroughs, with very high prices. Many new, expensive me-too drugs are not necessarily better than older and less expensive drugs. Most of the time they are compared with placebos and not older drug comparisons.

“Me-too” drugs are responsible for 80% of increased spending in recent years, and on average they are four times more expensive than the comparable, older alternatives10. By Patented Medicines Pricing Review Board’s (PMPRB) definitions, at the time of their introduction “me-too” drugs were judged to provide moderate, little or no improvement – in terms of effectiveness and safety – compared to older alternatives. However, on average, “me-too” drugs cost about 2.5 times as much per prescription as comparable older drugs. The question is whether the perceived or real differences justify the increased costs. New drugs do have a role in some situations and for some patients. However, it makes sense to use the older equally effective drugs whenever possible11.

Changing FDA rules to discourage me-too drug approvals would make R&D far more expensive, would discourage competition and therefore raise healthcare costs, and would forestall the wave of new research that has revolutionized our scientific understanding of the therapeutic categories where competition has been most intense.

Conclusion

New drugs are not required to improve on old ones, and there’s usually no way to know whether they do. Although the FDA must test drugs before they are marketed, they don’t need to be compared with similar drugs already on the market. The FDA only requires they be reasonably safe and better than nothing-a low standard indeed. This loophole in FDA regulations opens the door for an unlimited number of me-too drugs, which are easier to develop than innovative drugs.

Given everything, it should come as no surprise that these more expensive “me-too” drugs cost the medical industry money. The prevalence of the me-too’s really says an awful lot about the lack of innovation within the pharmaceutical industry. If you look at the new drugs marketed over the last six years, 78 percent weren’t even new chemical compounds. They were just new combinations or different formulations of old drugs. And 68 percent were classified by the F.D.A. as unlikely to be improvements over drugs already on pharmacy shelves.

At the same time, there are shortages of some important drugs that the pharmaceutical companies aren’t much interested in making because they are not as profitable as the me-too’s. But the companies don’t have to turn out needed drugs, if they are not lucrative. And they don’t.

References

1. http://www.medterms.com/script/main/art.asp?articlekey=33748

2. http://www.motherjones.com/news/qa/2004/09/09_401.html

3. http://polyscience.org/2005/09/me-too-drugs

4. http://www.shvoong.com/books/465475-me-too-drugs

5. http://www.pharmabiz.com/article/detnews.asp?SecArch=&articleid=14604&sectionid=46

6. http://direct.bl.uk/bld/PlaceOrder.do?UIN=162532605&ETOC=RN&from=searchengine

7. http://www.archivum.info/sci.med/2005-09/msg00257.html

8. http://www.aei.org/publications/filter.all,pubID.27443/pub_detail.asp

9. http://blogs.wsj.com/health/2007/05/17/in-praise-of-me-too-drugs

10. http://www.chepa.org/KnowledgeExchange/LabelleLectureship/tabid/84/Default.aspx

11. http://www.ti.ubc.ca/pages/letter59.html

Powered By Rxid.com

Tags: "me-too" Drugs, Fda, Medical Industry, Patent, Pharmaceutical Companies
Posted in Drugs | No Comments »