GLG News by Generic Drug Economic Experts

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

Generic Drug Profits: Too High or Appropriate Incentive?

September 11, 2008

Analysis of:Medicare overpaid on drugs with new generics, report says | www.latimes.com

A new OIG report highlights supposed “excess” payments by Medicare’s cost-plus drug reimbursement model, giving us a peek at the time path of generic margins in the Part B program. However, OIG overstates their case by ignoring the powerful incentives for rapid generic substitution that are created by higher profits early in the generic life cycle. Pay attention to this report because it illustrates the generic drug profit dynamics that exist elsewhere in healthcare – retail pharmacies, providers, wholesalers, and PBM mail order. And as generic utilization rates will move toward 75 percent over the next few years, I expect that pharmacy channel margins on generic drugs will be increasingly seen as a mechanism by which payors can manage their drug trend.

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

Progress on Federal Pedigree Will be Slow

September 5, 2008

Analysis of:Drug Stores Don’t See Progress for Electronic Drug-Pedigree Bill | fdanews.com

Representatives Steve Buyer (R-IN), Gene Green (D-TX), Jim Matheson (D-UT), and Mike Rogers (R-MI) co-sponsored H.R. 5839 Safeguarding America’s Pharmaceuticals Act of 2008. H.R. 5839 was going to be incorporated into other related FDA legislation, but intense behind-the scenes lobbying by the pharmacy industry against the bill has now stopped that option. However, I believe that it would be best for the FDA to implement national serialized e-pedigree in sync with a new California timeline. Although the FDA has not decided on its next step, I presume that nothing will happen until after the Presidential election and a possible new FDA commissioner.

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

CA E-Pedigree Delayed to 2015

September 4, 2008

Analysis of:Bill to track medicines is praised | www.signonsandiego.com

Implementation of California’s e-pedigree law has (probably) been pushed back to 2015. The widespread industry support for the bill makes me believe that the 2015 date might actually stick. The more realistic timeline should encourage pharmaceutical manufacturers to get serious about mass serialization for their products – a necessary first step for California’s vision of serialized e-pedigree. I expect that “mass serialization” will become increasingly important for supply chain security efforts at multinational drug makers, especially given the new serialization requirements in countries such as Belgium, Italy, and Turkey. The new California legislation also clears the way for a Federal approach to serialized e-pedigree by setting strong federal pre-emption language.

William FinkPresidentManaged Care Pharmacy Consultants, Inc

Dangers of Methadone Usage

August 28, 2008

Analysis of:Dr. Mark Yergin testifies to Congress | www.nytimes.com

Doctors must be educated on the correct use of Methadone if unnecessary deaths are to be avoided.

Eric GruffPrincipalE4 Consulting

Link to Pancreatitis is Bound to Negatively Impact Byetta Sales

August 21, 2008

Analysis of:FDA Alert: Hemorrhagic or Necrotizing Pancreatitis in Patients Taking Byetta | www.fda.gov

The recent publication of new cases of pancreatitis that are occurring in patients taking Byetta (exenatide) can't be good for Amylin/Lilly. While Byetta and investigational GLP-1 analogs are still very viable therapeutics for Type 2 Diabetes, prescribers will have to reassess the risk-benefit ratio for many patients given the new information. The long-acting form of Byetta (LAR) may suffer the most since its long half-life will make reversal of pancreatitis that much more difficult and may lead to additional damage.

Joseph BertinoIndependent ConsultantBertino Consulting

Astra-Zeneca and Abbott partner on promoting Crestor..should Pfizer beware?

August 15, 2008

Analysis of:Abbott signs deal to promote Crestor in U.S. | www.chicagotribune.com

-Crestor sold 2.8 billion dollars in sales in the recent year, will this partnership result in long term exponential growth? -What are the implications for Crestor with generic simvastatin and with Lipitor going generic in the next few years? -Is a combination product going to bolster Crestor sales?

Evan SiegelAdjunct Professor THE UNIVERSITY OF QUEENSLAND

A Complex Personal and Societal Issue

July 17, 2008

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.

Joseph BertinoIndependent ConsultantBertino Consulting

The New PhRMA “Code on Interactions with Health Care Professionals”: What will it mean?

July 17, 2008

Analysis of:PhRMA “Code on Interactions with Health Care Professionals” | www.thepinksheet.com

-The new code will limit all gifts and meals to healthcare professionals, thus reducing pharmaceutical representative contact time. -Medical education programs will follow guidelines established by professional education groups -The guidelines do not go far enough for sales representative-healthcare professional interactions

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC

California Debates a Tougher Drug Supply Chain Law

July 9, 2008

Analysis of:Time To Protect The Pharmaceutical Supply Chain | www.capitolweekly.net

State Senator Mark Ridley-Thomas’ editorial argues California needs its own pharmaceutical supply chain security laws because the Federal government has failed to implement the Prescription Drug Marketing Act (PDMA). However, it does not necessarily follow that every individual state pharmacy board should establish unique documentation requirements for manufacturers, wholesalers and pharmacies operating within each state. This approach has already created a disparate patchwork of inconsistent regulations for tracking pharmaceuticals in the U.S. supply chain. In the absence of federal standards, ambitious local politicians around the country are establishing their own incompatible systems, raising costs, reducing product availability, and lowering patient safety. 

Evan SiegelAdjunct Professor THE UNIVERSITY OF QUEENSLAND

A Word to the Wise...

July 8, 2008

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.

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