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	<title>Comments for Pharma Reform</title>
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	<link>http://www.pharmareform.com</link>
	<description>Transforming Pharmaceutical Companies in an era of Healthcare Reform</description>
	<lastBuildDate>Wed, 13 Feb 2013 18:02:32 +0000</lastBuildDate>
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		<title>Comment on Is Big Pharma Manufacturing Expertise Becoming a Misnomer? by Mike Wokasch</title>
		<link>http://www.pharmareform.com/2011/11/22/is-big-pharma-manufacturing-expertise-becoming-a-misnomer/comment-page-1/#comment-2073</link>
		<dc:creator>Mike Wokasch</dc:creator>
		<pubDate>Wed, 13 Feb 2013 18:02:32 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1290#comment-2073</guid>
		<description><![CDATA[Denise,
Thank you for your question.  You may already know that several Big Pharmas (e.g., Sanofi, GSK, Novartis) are making significant investments in Africa already. As suggested in my post, multidisciplinary manufacturing expertise is required for consistent, high quality cGMP-compliant pharmaceutical manufacturing.  While other issues may play a role (e.g., regulatory standards, regional law, and governmental stability) availability of the required expertise (not just trained technicians) may be the rate limiting factor for growing manufacturing operations in Africa. mike@pharmareform.com]]></description>
		<content:encoded><![CDATA[<p>Denise,<br />
Thank you for your question.  You may already know that several Big Pharmas (e.g., Sanofi, GSK, Novartis) are making significant investments in Africa already. As suggested in my post, multidisciplinary manufacturing expertise is required for consistent, high quality cGMP-compliant pharmaceutical manufacturing.  While other issues may play a role (e.g., regulatory standards, regional law, and governmental stability) availability of the required expertise (not just trained technicians) may be the rate limiting factor for growing manufacturing operations in Africa. <a href="mailto:mike@pharmareform.com">mike@pharmareform.com</a></p>
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		<title>Comment on Is Big Pharma Manufacturing Expertise Becoming a Misnomer? by Denise L Harrison</title>
		<link>http://www.pharmareform.com/2011/11/22/is-big-pharma-manufacturing-expertise-becoming-a-misnomer/comment-page-1/#comment-2072</link>
		<dc:creator>Denise L Harrison</dc:creator>
		<pubDate>Wed, 13 Feb 2013 09:59:45 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1290#comment-2072</guid>
		<description><![CDATA[I enjoyed your article. Good insight. Do you think big pharma will partner more with African pharma helping this region gain more pharma tech ability?]]></description>
		<content:encoded><![CDATA[<p>I enjoyed your article. Good insight. Do you think big pharma will partner more with African pharma helping this region gain more pharma tech ability?</p>
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		<title>Comment on Healthcare Reform Impact on Prescription Drugs by Mike Wokasch</title>
		<link>http://www.pharmareform.com/2010/03/22/healthcare-reform-impact-on-prescription-drugs/comment-page-1/#comment-1790</link>
		<dc:creator>Mike Wokasch</dc:creator>
		<pubDate>Sat, 27 Oct 2012 14:41:30 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=295#comment-1790</guid>
		<description><![CDATA[Daniel,
I have written a number of blog posts addressing how pharma companies can market and sell in this evolving new healthcare market (just click on the marketing or sales tags). The biggest changes that have affected the traditional sales and marketing tactics are access to physicians (reps and pharma marketing are no longer considered important/credible/reliable sources of product information), more rigorous critical reviews for managed market formularies and subsequent diminishing role of physicians in product choice, healthcare reform, and regulatory/legal constraints. Any new strategies or tactics have to take these into consideration and should start by developing better clinical and cost benefit data to support any claims you intend to make about a product. mike@pharmareform.com]]></description>
		<content:encoded><![CDATA[<p>Daniel,<br />
I have written a number of blog posts addressing how pharma companies can market and sell in this evolving new healthcare market (just click on the marketing or sales tags). The biggest changes that have affected the traditional sales and marketing tactics are access to physicians (reps and pharma marketing are no longer considered important/credible/reliable sources of product information), more rigorous critical reviews for managed market formularies and subsequent diminishing role of physicians in product choice, healthcare reform, and regulatory/legal constraints. Any new strategies or tactics have to take these into consideration and should start by developing better clinical and cost benefit data to support any claims you intend to make about a product. <a href="mailto:mike@pharmareform.com">mike@pharmareform.com</a></p>
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		<title>Comment on Healthcare Reform Impact on Prescription Drugs by Daniel</title>
		<link>http://www.pharmareform.com/2010/03/22/healthcare-reform-impact-on-prescription-drugs/comment-page-1/#comment-1785</link>
		<dc:creator>Daniel</dc:creator>
		<pubDate>Wed, 24 Oct 2012 18:20:12 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=295#comment-1785</guid>
		<description><![CDATA[Dear Mike, 

I am a recent Emory graduate who is preparing for consulting interviews with topics related to the Healthcare industry.  As a learner and a young person interested in learning about the future of healthcare in general, I fould your article extremely insightful.

I do have one question that I would like to better understand:  You comment that, &quot;Traditional sales and marketing will have less influence on product availability at the prescription drug plan level and even less influence on physician prescribing practices.&quot;  What actions, then, can drug producers take to ensure their products get into the prescribed available streams of medications by doctors (becoming competitive for the future), given that non-performers will be phased out and traditional marketing by drug companies may be less relevant in the treatment selection process.  

Many thanks!]]></description>
		<content:encoded><![CDATA[<p>Dear Mike, </p>
<p>I am a recent Emory graduate who is preparing for consulting interviews with topics related to the Healthcare industry.  As a learner and a young person interested in learning about the future of healthcare in general, I fould your article extremely insightful.</p>
<p>I do have one question that I would like to better understand:  You comment that, &#8220;Traditional sales and marketing will have less influence on product availability at the prescription drug plan level and even less influence on physician prescribing practices.&#8221;  What actions, then, can drug producers take to ensure their products get into the prescribed available streams of medications by doctors (becoming competitive for the future), given that non-performers will be phased out and traditional marketing by drug companies may be less relevant in the treatment selection process.  </p>
<p>Many thanks!</p>
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		<title>Comment on Why so many Surprising Disappointments from Pharmaceutical R &amp; D? by Mike Wokasch</title>
		<link>http://www.pharmareform.com/2012/08/28/why-so-many-surprising-disappointments-from-pharmaceutical-r-d/comment-page-1/#comment-1672</link>
		<dc:creator>Mike Wokasch</dc:creator>
		<pubDate>Tue, 28 Aug 2012 20:43:56 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1359#comment-1672</guid>
		<description><![CDATA[stacy,
Thanks for your comment. I believe that by the time a company gets to the FDA approval stage there should be no surprises, including what the outcome is going to be.  You gave me an idea for another post. Thank you. mike@pharmareform.com]]></description>
		<content:encoded><![CDATA[<p>stacy,<br />
Thanks for your comment. I believe that by the time a company gets to the FDA approval stage there should be no surprises, including what the outcome is going to be.  You gave me an idea for another post. Thank you. <a href="mailto:mike@pharmareform.com">mike@pharmareform.com</a></p>
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		<title>Comment on Why so many Surprising Disappointments from Pharmaceutical R &amp; D? by stacy</title>
		<link>http://www.pharmareform.com/2012/08/28/why-so-many-surprising-disappointments-from-pharmaceutical-r-d/comment-page-1/#comment-1671</link>
		<dc:creator>stacy</dc:creator>
		<pubDate>Tue, 28 Aug 2012 17:32:08 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1359#comment-1671</guid>
		<description><![CDATA[Its a shame when companies get rejected during the FDA approval process. They spend months or years working to end in failure. You have to keep moving forward and doing your best to abide with ISO requirements. Its all we can do.]]></description>
		<content:encoded><![CDATA[<p>Its a shame when companies get rejected during the FDA approval process. They spend months or years working to end in failure. You have to keep moving forward and doing your best to abide with ISO requirements. Its all we can do.</p>
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		<title>Comment on How to Stop &#8220;Off-Label&#8221; Marketing and Sales of Prescription Drugs by Mike Wokasch</title>
		<link>http://www.pharmareform.com/2012/02/01/how-to-stop-off-label-marketing-and-sales-of-prescription-drugs/comment-page-1/#comment-1654</link>
		<dc:creator>Mike Wokasch</dc:creator>
		<pubDate>Wed, 25 Jul 2012 13:40:50 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1330#comment-1654</guid>
		<description><![CDATA[Dr. Lennox,
You raise some interesting points.  I believe your concerns about the &quot;rip-off clone&quot; is not necessarily a bad thing if it actually leads to a better drug, more effective and/or fewer side effects. Unfortunately, the innovator company rarely feels compelled to pursue these opportunities in favor of focused development on the known &quot;lead compound.&quot;  At the same time, if the follow-on compounds are merely &quot;me-too&quot; drugs, the only benefit to patients is potentially keeping prices of the innovator product at a reasonably competitive level. I don&#039;t believe this is an area that should be regulated but rather let the patent process and market determine the novelty and value. mike@pharmareform.com]]></description>
		<content:encoded><![CDATA[<p>Dr. Lennox,<br />
You raise some interesting points.  I believe your concerns about the &#8220;rip-off clone&#8221; is not necessarily a bad thing if it actually leads to a better drug, more effective and/or fewer side effects. Unfortunately, the innovator company rarely feels compelled to pursue these opportunities in favor of focused development on the known &#8220;lead compound.&#8221;  At the same time, if the follow-on compounds are merely &#8220;me-too&#8221; drugs, the only benefit to patients is potentially keeping prices of the innovator product at a reasonably competitive level. I don&#8217;t believe this is an area that should be regulated but rather let the patent process and market determine the novelty and value. <a href="mailto:mike@pharmareform.com">mike@pharmareform.com</a></p>
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		<title>Comment on New Work Rules for Pharmaceutical Sales Representatives by Mike Wokasch</title>
		<link>http://www.pharmareform.com/2011/07/27/new-work-rules-for-pharmaceutical-sales-representatives/comment-page-1/#comment-1653</link>
		<dc:creator>Mike Wokasch</dc:creator>
		<pubDate>Wed, 25 Jul 2012 13:27:29 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1218#comment-1653</guid>
		<description><![CDATA[Vipin,
I&#039;m not sure how you overcome your work situation, especially if it is the industry norm.  If it is not the industry norm, you can always look to work for a company that will provide a better work situation for you. mike@pharmareform.com]]></description>
		<content:encoded><![CDATA[<p>Vipin,<br />
I&#8217;m not sure how you overcome your work situation, especially if it is the industry norm.  If it is not the industry norm, you can always look to work for a company that will provide a better work situation for you. <a href="mailto:mike@pharmareform.com">mike@pharmareform.com</a></p>
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		<title>Comment on New Work Rules for Pharmaceutical Sales Representatives by Vipin Garg</title>
		<link>http://www.pharmareform.com/2011/07/27/new-work-rules-for-pharmaceutical-sales-representatives/comment-page-1/#comment-1643</link>
		<dc:creator>Vipin Garg</dc:creator>
		<pubDate>Tue, 10 Jul 2012 13:16:08 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1218#comment-1643</guid>
		<description><![CDATA[In India pharma Rep  are in the worst condition. No 8 hour working, no over time even MER, LTA is included in the package. Overburdened by paper work which is of no use and the job has lost the attraction.  Lowest salaries amongst any industry. How to over come?]]></description>
		<content:encoded><![CDATA[<p>In India pharma Rep  are in the worst condition. No 8 hour working, no over time even MER, LTA is included in the package. Overburdened by paper work which is of no use and the job has lost the attraction.  Lowest salaries amongst any industry. How to over come?</p>
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		<title>Comment on How to Stop &#8220;Off-Label&#8221; Marketing and Sales of Prescription Drugs by Dr. Joseph Lennox</title>
		<link>http://www.pharmareform.com/2012/02/01/how-to-stop-off-label-marketing-and-sales-of-prescription-drugs/comment-page-1/#comment-1634</link>
		<dc:creator>Dr. Joseph Lennox</dc:creator>
		<pubDate>Tue, 26 Jun 2012 00:11:31 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1330#comment-1634</guid>
		<description><![CDATA[Mike,

I really like what you&#039;re doing here. The pharmaceutical industry has turned into a callous profit-driven machine that is insensitive to the human element unless such sensitivity has political value to make them appear &quot;almost human.&quot;

Off-label promotion needs to be stopped because there&#039;s not enough research involved in determination of metabolic pathways involved in alternative therapeutic indications especially when such indications are potentially being treated by other drugs. There&#039;s not enough resources in any company to research the effect of their drug on other disease states, and whether use of such a drug might exacerbate symptoms. There&#039;s most certainly not enough resources to study drug interactions from people being treated for multiple conditions.

A very &quot;innocent&quot; example is Lyrica. Pfizer made Lyrica for the treatment of fibromyalgia, however many psychiatrists have been using it as an anxiolytic to avoid the use of benodiazepines. Interestingly, Lyrica is MORE addictive than benzodiazepines, and the withdrawal. Hence, psychiatrists have created &quot;addicts&quot; by using a drug for purposes other than it&#039;s evaluated therapeutic indication.

There&#039;s another are of the pharmaceutical industry that needs to be regulated, and that&#039;s the common practice of &quot;rip-off clone&quot; drugs. Enclosed is an article (1500 words) that details my point.

http://lennoxtutoring.com/2012/06/21/pharmaceutical-industry-hidden-secrets/

If you need to delete the link, I understand. I looked for an email address for you, however could not find it.

Please keep up the good work on this excellent blog. I would enjoy a chat with you some day.

Kindest Regards,
Joseph R. Lennox, Ph.D.]]></description>
		<content:encoded><![CDATA[<p>Mike,</p>
<p>I really like what you&#8217;re doing here. The pharmaceutical industry has turned into a callous profit-driven machine that is insensitive to the human element unless such sensitivity has political value to make them appear &#8220;almost human.&#8221;</p>
<p>Off-label promotion needs to be stopped because there&#8217;s not enough research involved in determination of metabolic pathways involved in alternative therapeutic indications especially when such indications are potentially being treated by other drugs. There&#8217;s not enough resources in any company to research the effect of their drug on other disease states, and whether use of such a drug might exacerbate symptoms. There&#8217;s most certainly not enough resources to study drug interactions from people being treated for multiple conditions.</p>
<p>A very &#8220;innocent&#8221; example is Lyrica. Pfizer made Lyrica for the treatment of fibromyalgia, however many psychiatrists have been using it as an anxiolytic to avoid the use of benodiazepines. Interestingly, Lyrica is MORE addictive than benzodiazepines, and the withdrawal. Hence, psychiatrists have created &#8220;addicts&#8221; by using a drug for purposes other than it&#8217;s evaluated therapeutic indication.</p>
<p>There&#8217;s another are of the pharmaceutical industry that needs to be regulated, and that&#8217;s the common practice of &#8220;rip-off clone&#8221; drugs. Enclosed is an article (1500 words) that details my point.</p>
<p><a href="http://lennoxtutoring.com/2012/06/21/pharmaceutical-industry-hidden-secrets/" rel="nofollow">http://lennoxtutoring.com/2012/06/21/pharmaceutical-industry-hidden-secrets/</a></p>
<p>If you need to delete the link, I understand. I looked for an email address for you, however could not find it.</p>
<p>Please keep up the good work on this excellent blog. I would enjoy a chat with you some day.</p>
<p>Kindest Regards,<br />
Joseph R. Lennox, Ph.D.</p>
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		<title>Comment on Comparative Effectiveness and the SATURN study Comparing Crestor with Lipitor by jim frederick</title>
		<link>http://www.pharmareform.com/2011/09/12/comparative-effectiveness-and-the-saturn-study-comparing-crestor-with-lipitor/comment-page-1/#comment-1619</link>
		<dc:creator>jim frederick</dc:creator>
		<pubDate>Sat, 21 Apr 2012 11:54:16 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1246#comment-1619</guid>
		<description><![CDATA[I was put on Lipitor by my physician 6 years ago and had masive headaches including Migranes. He switched me to Zocor and I had a constant dull headache and felt a little &quot;fuzzy&quot; all the time. I tollerated that for a month. When I went back for a consultation with my Dr. he said I may have an intolerance for Niacin so he put me on Crestor 10mg. I have been on it every since with no side effects. My lowered my bad colesteral to normal levels and raised my good colesteral so much my dr thinks I work out a lot.]]></description>
		<content:encoded><![CDATA[<p>I was put on Lipitor by my physician 6 years ago and had masive headaches including Migranes. He switched me to Zocor and I had a constant dull headache and felt a little &#8220;fuzzy&#8221; all the time. I tollerated that for a month. When I went back for a consultation with my Dr. he said I may have an intolerance for Niacin so he put me on Crestor 10mg. I have been on it every since with no side effects. My lowered my bad colesteral to normal levels and raised my good colesteral so much my dr thinks I work out a lot.</p>
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		<title>Comment on How to Stop &#8220;Off-Label&#8221; Marketing and Sales of Prescription Drugs by Kimberly</title>
		<link>http://www.pharmareform.com/2012/02/01/how-to-stop-off-label-marketing-and-sales-of-prescription-drugs/comment-page-1/#comment-1592</link>
		<dc:creator>Kimberly</dc:creator>
		<pubDate>Fri, 03 Feb 2012 03:57:38 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1330#comment-1592</guid>
		<description><![CDATA[That makes perfect sense.  Well thought out and stated.  Thank you!]]></description>
		<content:encoded><![CDATA[<p>That makes perfect sense.  Well thought out and stated.  Thank you!</p>
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		<title>Comment on How to Stop &#8220;Off-Label&#8221; Marketing and Sales of Prescription Drugs by Mike Wokasch</title>
		<link>http://www.pharmareform.com/2012/02/01/how-to-stop-off-label-marketing-and-sales-of-prescription-drugs/comment-page-1/#comment-1590</link>
		<dc:creator>Mike Wokasch</dc:creator>
		<pubDate>Wed, 01 Feb 2012 22:44:58 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1330#comment-1590</guid>
		<description><![CDATA[Kimberly,
Thanks for the good question.  I don&#039;t believe this has anything to do with stunting innovation.  In no way is physician prescribing inhibited or limited in this scenario.  I am merely proposing that physicians, patients, and payers assume responsibility and accountability for their choice to prescribe, use, or pay for an unapproved use.  I feel this is fair and appropriate. It has been too financially rewarding, incentivized and encouraged by reimbursement, to keep Pharma Companies from engaging in &quot;off-label&quot; promotion. As I state, that doesn&#039;t make it right and Pharma Companies should not be promoting their products for unapproved uses. At the same time, it has been too easy for the government and patients to use &quot;off-label&quot; promotion as the basis for litigating to multimillion dollar awards and settlements despite the fact that three other entities (physician, patient, and payer) all made choices to use a product for the unapproved indication. It&#039;s almost as if Pharma companies are being blamed for forcing physicians to prescribe, forcing patients to take to the drugs, and forcing payers to reimburse for the unapproved use. Although Pharma Companies benefit from &quot;off-label&quot; use, they have no capacity to prescribe, to make patients take drugs, or to approve payer reimbursement.  mike@pharmareform.com]]></description>
		<content:encoded><![CDATA[<p>Kimberly,<br />
Thanks for the good question.  I don&#8217;t believe this has anything to do with stunting innovation.  In no way is physician prescribing inhibited or limited in this scenario.  I am merely proposing that physicians, patients, and payers assume responsibility and accountability for their choice to prescribe, use, or pay for an unapproved use.  I feel this is fair and appropriate. It has been too financially rewarding, incentivized and encouraged by reimbursement, to keep Pharma Companies from engaging in &#8220;off-label&#8221; promotion. As I state, that doesn&#8217;t make it right and Pharma Companies should not be promoting their products for unapproved uses. At the same time, it has been too easy for the government and patients to use &#8220;off-label&#8221; promotion as the basis for litigating to multimillion dollar awards and settlements despite the fact that three other entities (physician, patient, and payer) all made choices to use a product for the unapproved indication. It&#8217;s almost as if Pharma companies are being blamed for forcing physicians to prescribe, forcing patients to take to the drugs, and forcing payers to reimburse for the unapproved use. Although Pharma Companies benefit from &#8220;off-label&#8221; use, they have no capacity to prescribe, to make patients take drugs, or to approve payer reimbursement.  <a href="mailto:mike@pharmareform.com">mike@pharmareform.com</a></p>
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		<title>Comment on How to Stop &#8220;Off-Label&#8221; Marketing and Sales of Prescription Drugs by Kimberly</title>
		<link>http://www.pharmareform.com/2012/02/01/how-to-stop-off-label-marketing-and-sales-of-prescription-drugs/comment-page-1/#comment-1589</link>
		<dc:creator>Kimberly</dc:creator>
		<pubDate>Wed, 01 Feb 2012 20:58:53 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1330#comment-1589</guid>
		<description><![CDATA[This would be very effective in stopping off-label promotion.  The portion that has to do with promotion should happen tomorrow.  I am, however, concerned that by restricting the ability of physicians to prescribe drugs as they see fit we could stunt innovation.  What do you think?]]></description>
		<content:encoded><![CDATA[<p>This would be very effective in stopping off-label promotion.  The portion that has to do with promotion should happen tomorrow.  I am, however, concerned that by restricting the ability of physicians to prescribe drugs as they see fit we could stunt innovation.  What do you think?</p>
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		<title>Comment on What can FDA really do about drug shortages? by Mike Wokasch</title>
		<link>http://www.pharmareform.com/2011/11/02/what-can-fda-really-do-about-drug-shortages/comment-page-1/#comment-1421</link>
		<dc:creator>Mike Wokasch</dc:creator>
		<pubDate>Thu, 03 Nov 2011 13:43:50 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1273#comment-1421</guid>
		<description><![CDATA[Ken,
Thank you for your comment.  You raise two important issues.  One is an appreciation for the expense of maintaining and fixing a prescription drug manufacturing process.  The second is whether or not the government should financially subsidize the fix when critical medicines are involved.

Keep in mind that many of these products are generic drugs and generic drug companies run on very thin profit margins.  Maintaining the facility, process, and quality system requirements to manufacture prescription drugs to cGMP compliant standards is expensive, even for generic drugs and especially for sterile injectable products.  Fixing manufacturing or quality problems, even for easy-to-manufacture products, is not a simple or inexpensive process.  Diagnosing the problem, determining a fix, and then putting in place a solution followed by validation (practice runs to get it right and prove it works consistently, run after run) all take expertise, money, and time. This can be further compromised by older facilities and outdated equipment or machinery.  I’m sure many of the products on the shortage list also probably have complex processes (not easily or inexpensive to fix) for making either the active pharmaceutical ingredient and/or the final finished product. 

Whether the government should help pay for these fixes to maintain a supply of critical medicines is more a political, philosophical issue.  I personally see this as a market issue.  If the market feels they are critical medicines and patients need them, the market and patients should be willing to pay a price that better represents their value.  mike@pharmareform.com]]></description>
		<content:encoded><![CDATA[<p>Ken,<br />
Thank you for your comment.  You raise two important issues.  One is an appreciation for the expense of maintaining and fixing a prescription drug manufacturing process.  The second is whether or not the government should financially subsidize the fix when critical medicines are involved.</p>
<p>Keep in mind that many of these products are generic drugs and generic drug companies run on very thin profit margins.  Maintaining the facility, process, and quality system requirements to manufacture prescription drugs to cGMP compliant standards is expensive, even for generic drugs and especially for sterile injectable products.  Fixing manufacturing or quality problems, even for easy-to-manufacture products, is not a simple or inexpensive process.  Diagnosing the problem, determining a fix, and then putting in place a solution followed by validation (practice runs to get it right and prove it works consistently, run after run) all take expertise, money, and time. This can be further compromised by older facilities and outdated equipment or machinery.  I’m sure many of the products on the shortage list also probably have complex processes (not easily or inexpensive to fix) for making either the active pharmaceutical ingredient and/or the final finished product. </p>
<p>Whether the government should help pay for these fixes to maintain a supply of critical medicines is more a political, philosophical issue.  I personally see this as a market issue.  If the market feels they are critical medicines and patients need them, the market and patients should be willing to pay a price that better represents their value.  <a href="mailto:mike@pharmareform.com">mike@pharmareform.com</a></p>
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		<title>Comment on What can FDA really do about drug shortages? by ken</title>
		<link>http://www.pharmareform.com/2011/11/02/what-can-fda-really-do-about-drug-shortages/comment-page-1/#comment-1418</link>
		<dc:creator>ken</dc:creator>
		<pubDate>Thu, 03 Nov 2011 08:52:49 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1273#comment-1418</guid>
		<description><![CDATA[Very interesting post. But why couldn&#039;t the FDA work with manufacturers to address regulatory concerns and even work with potential suppliers (essentially in an &quot;extension agent&quot; role) to raise quality levels, without this necessarily increasing prices? If having a stable supply of high quality drugs is a public good that the market alone is not providing, which is the clear take-away from this posting, then it makes sense for the government to step in and help supply the public good. I realize that may be infeasible, politically, in an era where everyone is obsessed with deficit reduction (and particularly deficit reduction by getting the government to spend less), but it strikes me as reasonable.]]></description>
		<content:encoded><![CDATA[<p>Very interesting post. But why couldn&#8217;t the FDA work with manufacturers to address regulatory concerns and even work with potential suppliers (essentially in an &#8220;extension agent&#8221; role) to raise quality levels, without this necessarily increasing prices? If having a stable supply of high quality drugs is a public good that the market alone is not providing, which is the clear take-away from this posting, then it makes sense for the government to step in and help supply the public good. I realize that may be infeasible, politically, in an era where everyone is obsessed with deficit reduction (and particularly deficit reduction by getting the government to spend less), but it strikes me as reasonable.</p>
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		<title>Comment on Comparative Effectiveness and the SATURN study Comparing Crestor with Lipitor by Mike Wokasch</title>
		<link>http://www.pharmareform.com/2011/09/12/comparative-effectiveness-and-the-saturn-study-comparing-crestor-with-lipitor/comment-page-1/#comment-1391</link>
		<dc:creator>Mike Wokasch</dc:creator>
		<pubDate>Wed, 21 Sep 2011 21:33:30 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1246#comment-1391</guid>
		<description><![CDATA[Ron,
Thanks for your comment.  Perhaps one of the greatest deficiencies of typical comparative effectiveness trials is that they are not designed to evaluate how individuals or even subgroups might benefit (or be more susceptible to adverse reaction) from one drug compared to the other.  They look at how the general population of patients (the masses) might respond to treatment.   This approach may benefit payers and patients for whom it makes no difference but it does not help patients (might even make it difficult for them to get the right drug or pay much more for the one that works for them) who might respond better to one compared to the other.  mike@pharmareform.com]]></description>
		<content:encoded><![CDATA[<p>Ron,<br />
Thanks for your comment.  Perhaps one of the greatest deficiencies of typical comparative effectiveness trials is that they are not designed to evaluate how individuals or even subgroups might benefit (or be more susceptible to adverse reaction) from one drug compared to the other.  They look at how the general population of patients (the masses) might respond to treatment.   This approach may benefit payers and patients for whom it makes no difference but it does not help patients (might even make it difficult for them to get the right drug or pay much more for the one that works for them) who might respond better to one compared to the other.  <a href="mailto:mike@pharmareform.com">mike@pharmareform.com</a></p>
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		<title>Comment on Comparative Effectiveness and the SATURN study Comparing Crestor with Lipitor by Ron Miklos</title>
		<link>http://www.pharmareform.com/2011/09/12/comparative-effectiveness-and-the-saturn-study-comparing-crestor-with-lipitor/comment-page-1/#comment-1390</link>
		<dc:creator>Ron Miklos</dc:creator>
		<pubDate>Wed, 21 Sep 2011 18:48:40 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1246#comment-1390</guid>
		<description><![CDATA[I have been on both of these drugs and Crestor, for me, was far superior to Lipitor. I had side effects with Lipitor. Crestor raised my HDL and lowered my bad cholesterol to normal levels. Having sold pharmaceuticals, there is no such thing as one size fits all. There is a danger in going to a strict formulary and all these statins are not created equal.]]></description>
		<content:encoded><![CDATA[<p>I have been on both of these drugs and Crestor, for me, was far superior to Lipitor. I had side effects with Lipitor. Crestor raised my HDL and lowered my bad cholesterol to normal levels. Having sold pharmaceuticals, there is no such thing as one size fits all. There is a danger in going to a strict formulary and all these statins are not created equal.</p>
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		<title>Comment on New Work Rules for Pharmaceutical Sales Representatives by Mike Wokasch</title>
		<link>http://www.pharmareform.com/2011/07/27/new-work-rules-for-pharmaceutical-sales-representatives/comment-page-1/#comment-1387</link>
		<dc:creator>Mike Wokasch</dc:creator>
		<pubDate>Thu, 15 Sep 2011 12:57:18 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1218#comment-1387</guid>
		<description><![CDATA[Yeoh,
Thank you for your comment. This is not about how to manage and motivate employees but rather the realities of the magnitude of change to expect if pharmaceutical sales representatives are classified as &quot;non-exempt hourly &quot; employees.  Trust and empowerment are important in an employer-employee relationship but from what I have read there is little flexibility in the law when it comes to making sure hourly employees accurately record their time on the job and are paid accordingly.  mike@pharmareform.com]]></description>
		<content:encoded><![CDATA[<p>Yeoh,<br />
Thank you for your comment. This is not about how to manage and motivate employees but rather the realities of the magnitude of change to expect if pharmaceutical sales representatives are classified as &#8220;non-exempt hourly &#8221; employees.  Trust and empowerment are important in an employer-employee relationship but from what I have read there is little flexibility in the law when it comes to making sure hourly employees accurately record their time on the job and are paid accordingly.  <a href="mailto:mike@pharmareform.com">mike@pharmareform.com</a></p>
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		<title>Comment on New Work Rules for Pharmaceutical Sales Representatives by Yeoh</title>
		<link>http://www.pharmareform.com/2011/07/27/new-work-rules-for-pharmaceutical-sales-representatives/comment-page-1/#comment-1385</link>
		<dc:creator>Yeoh</dc:creator>
		<pubDate>Thu, 15 Sep 2011 01:59:17 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmareform.com/?p=1218#comment-1385</guid>
		<description><![CDATA[This kind of regulations will greatly reduce the morale &amp; productivity of Pharma Companies - trust &amp; empowerment are two of the great factors in motivating an employee to churn out productivity &amp; creativity in line with the Pharma code of ethics. A certain amount of freedom which is not abused, can boost up the morale &amp; figthing spirit of field sales force rather than close scrutinity.]]></description>
		<content:encoded><![CDATA[<p>This kind of regulations will greatly reduce the morale &amp; productivity of Pharma Companies &#8211; trust &amp; empowerment are two of the great factors in motivating an employee to churn out productivity &amp; creativity in line with the Pharma code of ethics. A certain amount of freedom which is not abused, can boost up the morale &amp; figthing spirit of field sales force rather than close scrutinity.</p>
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