Whom Can Patients Rely On? - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Whom Can Patients Rely On?


Pharmaceutical Technology


Angie Drakulich
As the mother of a 15-month-old, I was quite shaken last month to hear about over-the-counter cold medicines for children under age 2 being pulled off the shelves. Glued to the news, I wondered if the decongestant I had given my daughter when she was sick would have any negative impact on her long-term health.

I started looking into the dosage approval process as well as how unapproved drugs—such as the cough suppressants containing hydrocodone currently being addressed by the US Food and Drug Administration—get on the market in the first place. According to FDA, several thousand drugs are marketed without going through its approval system. Many of these medications are marketed illegally; others were put on the market before 1962 when the government started requiring manufacturers to get product approval. Although the unapproved drug issue is not new, it wasn't until mid-2006 that FDA started to pay it serious attention by publishing a guidance on unapproved drugs, issuing more warning letters, and taking some illegal medications off the market.

But the lack of awareness of unapproved drugs needs to be addressed as well. A 2006 Medical Marketing Research survey showed that 91% of retail pharmacists believed all medication available for dispensing with a doctor's prescription had been FDA approved, even if it had not. According to CNN, doctors write approximately 65 million prescriptions every year for drugs not yet approved.

So my question is, if FDA can't control all the medications lining drugstore aisles, and neither the pharmacists or doctors are sure about which drugs have been approved, whom are patients to depend on? And when people of all ages are being harmed as a result, who is to blame?

In my view, responsibility lies with the drug manufacturer who failed to get the required drug approval. Sadly, if there's no one to trust, industry may be unintentionally provoking patients to avoid medicines, or to lean toward natural remedies, which is not fair to the manufacturers who are following the rules. Perhaps some peer pressure on their part is overdue.










Angie Drakulich, managing editor, Pharmaceutical Technology,

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
33%
Breakthrough designations
11%
Protecting the supply chain
39%
Expedited reviews of drug submissions
11%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here