Archive for 2007
BMA to attempt to control internet drug sales
A Growing Problem – China’s Control of Pharmaceuticals and Ingredients
Liang BA.* Safety Issues in Regulating Follow-On Biologic Drugs. J BIolaw Bus. 2007;10(4):44-49.
Biologic drugs are expensive, and hence policymakers are considering accelerating copies, or "follow on" biologic products to market using abbreviated pathways. However, important concerns relating to biologic products may have implications for follow on product regulation. The information gaps regarding biologic science, clinical issues associated with product excipients and active ingredient, and supply chain issues…
[...]Kubic TT.* Beer Cooler Biologics! J Biolaw Bus. 2007;10(4):28-32.
Every day, law enforcement officers throughout the United States are engaged in court authorized searches of persons, vehicles, homes and businesses. On occasion, during these searches, officers are surprised at what they uncover. For in some of the most unlikely places, their searches have disclosed the most advanced medicines – biologics, pharmaceuticals products critical to…
[...]Lammons KD. The October 2005 Fake Flu Vaccine Incident. J Biolaw Bus. 2007;10(4):40-43.
In October of 2005, Houston Texas was the site of a fake flu vaccine scam. Approximately 1400 persons were injected with a substance that was purported to be flu vaccine when in fact it was not. The investigation into this incident revealed that the victims had been injected with purified water and none of the…
[...]Class JN.* Behind the Curve: A Critique of NGO Activity with regards to the Safety Concerns of Biologics. J Biolaw Bus. 2007;10(4):33-36.
Non-governmental organizations, or NGOs, play a role in engaging the safety of biological medicines. NGOs should reconsider their roles as safety watchdogs in order to promote positive change with respect to biological medicines. Behind the Curve: A Critique of NGO Activity with regards to the Safety Concerns of Biologics
[...]Roberts R. Counterfeit Biologics: A Personal Narrative. J Biolaw Bus. 2007;10(4):37-39.
Counterfeit drugs are not something that happen to someone else. Real people are affected by fake drugs they buy in pharmacies. It is an experience that teaches us the importance of safety of the drug supply. I know, because I was a victim. This is my story.
[...]Generics Urged to Get Involved in Fight Against Counterfeiting
While counterfeiting is believed mainly to affect brand drugmakers, the practice, as well as various anticounterfeiting measures, has implications for generic companies, an industry expert says. In the U.S., political discussion of the pharmaceutical industry is focused on drug safety and the cost of healthcare, but in Europe a current hot-button issue is counterfeit medicines,…
[...]New drug scare
BEIJING – The medicine cabinet in the average U.S. home is filling with drugs made in China, and some experts say that could be a prescription for trouble. China's booming pharmaceutical industry has doubled exports to the United States in five years, undercutting competitors and making U.S. consumers reliant on the safety of Chinese factories…
[...]FDA proposes heavier fines for fake drug business
The Food and Drug Administration (FDA) is set to impose much higher fines on manufacturers, sellers and importers of fake drugs. The proposed amendment to the Drug Act of BE 2510 is seeking to fine fakedrug manufacturers up to Bt5 million, and sellers and importers up to Bt2 million. "Convicted offenders are also liable to…
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