Whom Can Patients Rely On?

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.

Angie Drakulich

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, adrakulich@advanstar.com