Introduction

Recalls of prescription and over the counter drugs are surging and raising questions about the quality of drug manufacturing in the United States.

Market withdrawal occurs when recalled products have quality issues, such as a higher concentration of the active ingredient than specified, substandard inactive ingredients, or impurities of unspecified origin.

Background
In May 2010, Johnson and Johnson voluntarily recalled all unexpired lots of certain over-the-counter (OTC) pediatric drugs, including Tylenol, after discovering manufacturing deficiencies affecting the quality, purity, or potency of the medicines. In September 2008, 21 pediatric Tylenol liquid products were deemed potentially unsafe due to bacterial contamination in one of the inactive ingredients. Such high-profile recalls have drawn attention to quality concerns in manufacturing.

The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices and for overseeing the manufacturing, performance, and safety of these devices. In 2007, 1,279 medical device products were recalled, and that number soared to 3,211 in 2011, according to CDRH data. The constantly soaring number of drug recalls raises questions over safety and efficacy of products. According to statistics from World Bank, the pharmaceutical industry is worth more money than the gross domestic product (GDP) of many countries. The drug prices are still rising every year, but manufacturers use costs as the excuse for failing to produce high-quality pure products.

Issue

Have drug companies been overlooking the quality of their products?

Rule

The recklessness of pharmaceutical companies is apparent if:

  1. The reasons behind the constantly increasing number of recalls are inferior and substandard quality of products
  2. The drug manufacturing and repackaging companies are responsible for the substandard quality

Analysis

Inferior/Substandard Products

GBI (Global Business Intelligence) Research is an agency that publishes in-depth strategic intelligence reports in a broad range of professional industries including pharmaceuticals. Its report, “Drug Recalls and Warning Letters – Increasing Numbers Caused by Manufacturing Errors and Regulatory Non-compliance Issues,” describes the in-depth analysis of Warning Letters and drug recalls. The report is built on data and information sourced from the FDA database of warning letters and drug recalls.

Drugs are recalled if they are a health hazard, mislabeled or packaged poorly, potentially contaminated, or poorly manufactured. A number of factors are fueling the recall surge. After drugs lose patent protection, the first applicant typically gets the lion’s share of the business for the new drug. So, there is a stampede by drug makers to be first to bring generic versions to market. In their hurry, they fail to adhere to the quality, labeling, or manufacturing guidelines.

Responsibility

Labeling errors, such as drug labels or prescription information that fails to provide information on the risks and side effects associated with use of drug, are also problems. Repackagers that relabel drugs into smaller units for resale or distribution to healthcare facilities have serious lapses.

Drugmakers are facing intense competition, and generic and over the counter drugs are not as profitable for them as prescription drugs. Hence, they are trimming manufacturing investment or outsourcing production, thus negatively affecting the resources to make high-quality, safe products.

Conclusion

The reasons behind the constantly increasing number of recalls are inferior and substandard quality of products due to overlooking of the manufacturing, labeling, and storage of the pharmaceuticals. The cost cutting strategies and unhealthy competition between the drug manufacturing and repackaging companies are responsible for the substandard quality and, hence, the recalls. The drug companies have been acting hastily and negligibly overlooking the quality of their products.

For more information on this issue, contact the Kulkarni Law Firm.