Tuesday, September 16, 2014

Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor

More insights in the full article: Foresight is 20/20: The Need For Pharmaceutical Companies to Implement Robust Anti-Corruption Programs - Pharmaceutical Compliance Monitor:

"In the wake of the recent FCPA enforcement activity, the government has signaled its renewed attention to pharmaceutical companies. It is therefore imperative that pharmaceutical companies doing business abroad assess their individual risks, develop compliance goals, and create and implement a comprehensive compliance program that evolves in conjunction their risk profile and ever-changing enforcement trends."

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Saturday, September 13, 2014

Poor Quality Drugs and Global Trade: A Pilot Study - NBER.org

Read the rest of the abstract: Poor Quality Drugs and Global Trade: A Pilot Study - NBER.org:

"Experts claim that some Indian drug manufacturers cut corners and make substandard drugs for markets with non-existent, under-developed or emerging regulatory oversight, notably Africa. This paper assesses the quality of 1470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries. We find that 10.9% of those products fail a basic assessment of active pharmaceutical ingredients (API), and the majority of the failures are substandard (7%) as they contain some correct API but the amount of API is under-dosed. The distribution of these substandard products is not random: they are more likely to be found as unregistered products in Africa than in India or non-African countries."

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Read the study paper:
Poor Quality Drugs and Global Trade: A Pilot Study (Roger Bate, Ginger Zhe Jin, Aparna Mathur, Amir Attaran). NBER Working Paper No. 20469. Issued in September 2014 (PDF)

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Friday, September 12, 2014

FDA could be source of innovation, Hamburg says - Denver Business Journal

Read the full article: FDA could be source of innovation, Hamburg says - Denver Business Journal:

"The FDA, in the course of approving new drugs and devices and overseeing their safety and effectiveness, gains broad knowledge of what companies are doing, what researchers are discovering about disease and how that relates to medical outcomes.

Hamburg’s vision is for the FDA to use that position to help researchers and companies make more effective new treatments and prove new medical advances more quickly, she said.

“We have a lot more to offer than has historically been appreciated,” said Hamburg, U.S. Commissioner of Food and Drugs since 2009. “The regulator has a very different role than the innovator or the academic researcher, but we can be a very effective partner for both.”"

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Wednesday, September 10, 2014

FDA - Biosimilars > Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

Read the full announcement: Biosimilars > Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations - FDA.gov:

"The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

Separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be updated periodically."

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