Free Newsletter
| Get the pharma industry's daily monitor, with a special focus on pharmaceutical company news and the market development of FDA approved products. Sign up for free today! |
Origin labeling a sticky pharma problem
Should drugs be labeled with their country of origin? Plenty of people have asked that question since the big heparin flap--in which hundreds of patients experienced severe reactions, even death, after using Baxter's blood thinner--exposed contamination problems in the drug's Chinese supply chain. Rep. John Dingell's plan (discussed here) endorses it. But because drug supply chains are so complex, winding through multiple countries, how would they be labeled? What info would be meaningful to consumers?
Drug companies are using this opportunity to say consumers should be alert to counterfeit products from outside the U.S. In other words, they're saying, buying your meds from countries where they're sold more cheaply could be dangerous. Never mind that the heparin that caused all the ruckus wasn't that sort of counterfeit, but distributed in the U.S. by a U.S. company--so consumers could have watched all day for signs of counterfeiting and never seen them. In fact, the signs were so subtle, it took a high-tech test to expose them.
Even consumer watchdog Public Citizen isn't convinced that "made in China" or "active ingredient sourced in India" would be meaningful for patients, though. It's just one more facet of the import-safety debate without a clear solution.
- read the Wall Street Journal article
Related Articles:
China: Buyers on hook for drug safety. Report
Overseas drugmaking goes unsupervised. Report
Counterfeiters lurk in free trade zones. Report
Counterfeit drugs plaguing Big Pharma. Report
Comments
The issue of identifying the source is mute. With a variety of global outsourcing who will become "the source". Furthermore, it this is for the benefit of the consumer, smaller dispensing vials do not indicate source.
Drugs should be labeled with 1. Made in country X, Y &... 2. Inactive ingredients & quantity 3. Actual amount of active ingredients 4. The +/- they are allowed to vary from stated amount of active ingredients (generics can vary from stated quantity by over 15%. Generics inactive ingredients do not always equal the original brand name content or quantity. I can buy underwear and know all of the above. The efficacy of generics does not always equal that of brand name. If the contents aren't equal, then the efficacy may not be. The FDA is aware of this!! Why can't we know everything about drugs that go into our body? We know the content of clothing placed on our body plus where they are made!!!! Good luck getting Congress to act on this one!!
Label a drug's origin as we do imported cars, e.g.
US/Canadian parts/ingredients content: 5%
Major Source of Foreign Ingredients: Germany 80%
Final Assembly of Product: Dingolfing, Germany
Country of Origin:
Engine: Germany
Transmission: Germany
Result = 2008 BMW 535xi
I will not list EPA Fuel Economy, Government Safety Ratings, Smog Emissions information, etc. If this can be done for an automobile, surely medical drugs Could be labeled appropriately???
Post new comment
Paid Research Reports
- RNA therapy: the next big thing after monoclonal antibodies?
- Biotech M&A Strategies: Deal assessments, trends and future prospects
- The Dermatology Market Outlook to 2013: Competitive landscape, pipeline analysis and growth opportunities
- Pipeline Insight: Cancer Overview - Breast, Gynecological, Genitourinary - Diverse drugs approaching the market for many tumor t
- Sales Force Effectiveness
- Forecast Model: Antidyslipidemics - Genericization and negative trial data drive market shrinkage


