Up Close and Personal - Pharmaceutical Technology

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Up Close and Personal
Regulators and standard-setting bodies are re-examining over-the-counter drugs.

Pharmaceutical Technology
Volume 35, Issue 5, pp. 44-50

Checking expectations

Many of the ongoing efforts described herein are aimed at improving OTC drug safety for consumers, and says CHPA's Spangler, "It doesn't take a whole lot of sophistication to observe that we're in an era of greater enforcement." These changes are good, he says, because industry ultimately wants to reassure consumers that products on the market are safe and meet quality standards.

That said, it is not official that OTC drug manufacturers will face higher levels of enforcement going forward. According to FDA, the agency's "standards that a marketed drug must have a favorable benefit-to-risk profile remain unchanged."

At the end of the day, consumers play a crucial role in OTC drug safety by their decisions to select and use these products properly. "Consumers should read the product labels carefully and should not throw away the boxes that have the Drug Facts information," points out FDA's Kubaska. Together, consumers, industry, and the authorities can make the drugstore shelf not just an easily accessible place, but a safer place.


1. FDA, "Regulation of Nonprescription Drug Products," presentation http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM148055.pdf.

2. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), Part 330.

3. FDA, "Compliance Program Guidance Manual," Chapter 61: OTC Drug Evaluation (Rockville, MD May 2007).

4. USP, Letter to USP from FDA, February 2011, http://www.usp.org/hottopics/monographs.html.

5. FDA, Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products (Rockville, MD, August 2010).

6. EMA, EMA/275297/2010 3/9 (Apr. 1, 2011).

7. EMA, Guideline on the Readability of the Labeling and Package Leaflet of Medicinal Products for Human Use (2009).

8. FDA, "Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program," Document 7356:002.

9. FDA, Guidance for Industry: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application (Rockville, MD, 2010.

Industry Comment:

Albemarle is a leading producer of active pharmaceutical ingredients (API) in the United States but we do not produce any dosage form pharmaceuticals for either prescription or OTC sale. Because of this, Albemarle views FDA’s enforcement efforts regarding OTCs through the eyes of the consumer, and there are several issues that affect OTC drugs that we would like to address.

Monograph modernization can be viewed to have both positive and negative effects. Any effort to replace outmoded and antiquated procedures with methods that are supported by the latest technology may involve the short term inconvenience and cost of conversion to new methods and instruments. However, this will ultimately help assure a safer and better quality product for the consuming public.

There is increased scrutiny by FDA on OTC medications because these products may be consumed without a prescription; thus causing them to be purchased more frequently and in larger quantities. In my opinion, FDA should focus more attention toward assuring the sources of APIs manufactured outside the United States have been produced according to cGMP guidelines and initiate a robust inspection plan to support this effort.

In the past, Western suppliers provided 90% of the active pharmaceutical ingredients to the US market. Today, foreign producers, primary in China and India, produce greater than 80% and this percentage is rising. In 1998, the US Government Accountability Office (GAO) determined that FDA did an inadequate job of performing foreign inspections. In the year 2000, FDA performed only 135 inspections of foreign API producers and since then, globalization has placed an incredible strain on FDA. FDA has made vast improvements to their performance, which is evidenced by their execution of 424 inspections in 2009. However, due to the growing number of foreign producers of APIs, the GAO estimates in a report published in September of 2010, that it would take 9 years for FDA to inspect all of the foreign facilities on its list. In contrast, FDA inspects domestic facilities approximately once every 2.5 years. According to the GAO report, FDA listed a total of 3,765 foreign establishments in its inventory in 2009.

Of this total, 2,394 establishments may never have been inspected because FDA could not identify a previous inspection for those establishments. The percentage of establishments in FDA’s inventory in China that may have never been inspected was 88%. As a consumer, I appreciate FDA’s efforts concerning enforcement and improvement on inspections. However, as the number and sheer volume of imported drugs continue to increase, FDA needs to dramatically improve its program for inspection of foreign establishments.

--Steve LeVan, vice-president of Fine Chemistry Services at Albermarle


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