Study Group: Council Members in the U.S. who are Familiar with Regulations Pertaining to Andrx Corporation's Form 483

GLG News^SM Analyses by this Study Group's Leading Experts(?)

Risk/Benefit is the Answer, Even More Now

December 22, 2008

Analysis by:Evan Siegel, Adjunct Professor ,

Analysis of:Tysabri - Multiple Sclerosis patient with progressive multifocal leukoencephalopathy has died | www.msrc.co.uk

1. In general, the more pharmacologically potent a therapy, the more the possibllity that adverse experiences will be seen. 2. Risk/Beneift is a critical consideration, even for products intented for serious or life-threatening disease. It is incumbent upon both the FDA and the physician community to realistically assess preclnical and clinical data during the review and approval process. 3. Patients must be fully and competently informed of the risks and benefits of such therapies and have the right to decide for themselves whether or not to participate in clinical trials and therapeutic treatment with marketed products. 4. No therapeutic regimen is risk-free and society needs to understand and embrace this fact.

A Complex Personal and Societal Issue

July 17, 2008

Analysis by:Evan Siegel, Adjunct Professor ,

Analysis of:Costly Cancer Drug Offers Hope, but Also a Dilemma | www.nytimes.com

The issues associated with expensive therapeutics are multifaceted and involve personal, professional and societal components. Value related to medical treatment is uniquely assessed by each individual with respect to his/her financial burden, overall lifestyle and quality of life, societal role, and belief structure. Society itself is beset with contrary stakeholders in the insurance, governmental, medical and belief-centered establishments. This article is important in that it lays out some fundamental questions that wealthy countries face with respect to cost vs. benefit for new therapies in an environment relatively little constrained by cost-containment in the medical arena.

A Word to the Wise...

July 8, 2008

Analysis by:Evan Siegel, Adjunct Professor ,

Analysis of:Drug Makers Say FDA Safety Focus Is Slowing New-Medicine Pipeline | online.wsj.com

1. Sponsors need to be "squeaky clean" with respect to their assessment of signals of toxicity in drug develpment programs. 2. This assessment should be made at the preclinical and early clinical stages of the process, irrespective of political and financial considerations. 3. The per cent of failures in Phase 2 and 3 will be higher unless programs are honestly and thoroughly assessed according to the above. Even so, there will likely be more failures in late-stage programs as clinical data are generated. The FDA will spend more time and effort on safety assessment to avoid large populations being exposed in the marketing environment to new drugs.

Just a Matter of Time

April 1, 2008

Analysis by:Evan Siegel, Adjunct Professor ,

Analysis of:The Drug Scare That Exposed a World of Hurt | www.nytimes.com

Overseas manufacturing controls for both APIs and finished drug products will need to be improved and the FDA will closely monitor compliance in an increased fashion. Drug regulation itself is not likely to change, but more inspections and more thorough review of DMFs and information submitted in support of late-stage INDs and NDAs/BLAs will occur. The FDA has been lax in assuring that the veritable explosion of outsourcing of raw material and API manufacture to third-world and emerging nations has been closely monitored for compliance with purity, potency and other requirements.

But What Does it Mean for The Patient in the Real Clinical Arena?

November 13, 2007

Analysis by:Evan Siegel, Adjunct Professor ,

Analysis of:NicOx' Naproxcinod ABPM Data Presented At American Heart Association | www.medicalnewstoday.com

1. The results are intriguing, but the clinical relevance for the large number of patients who could be exposed in the real-life clinical situation is uncertain. 2. The hypotheses for thsi program early-on seem to be supported by the phase 3 data to date, i.e., the nitro-comopounds may have actions that are different than their parent compounds. 3. It will be inteesting to see across finished studies what the actual effects on blood pressure may be.

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