Pharmaceutical Manufacturing Quality Issues

March 11, 2015    Article

Problems in pharmaceutical manufacturing have been attracting increasing attention and concern from both the market and regulators. A recent GAO (Government Accountability Office) report found that nearly 40% of drug shortages in the U.S. are caused by quality concerns related to the production process.

There are numerous regulatory requirements in place that are enforced by the Federal Drug Administration (FDA). These are broadly known as the Current Good Manufacturing Practices (cGMP). The cGMP regulations provide the minimum standards that manufacturers must comply with to ensure product safety. cGMP provides standards for the manufacturing process, safety, documentation and packaging of pharmaceuticals.

The FDA is charged with overseeing the quality of all drugs that are sold in the U.S. whether they are manufactured here or in another country. With the increase in manufacturing facilities outside the U.S., increased strain has been placed on inspectors who must not only travel around the world to inspect plants, but must also deal with a myriad of local issues and customs.

The shortage of critical drugs is attracting increased nationwide attention as news stories multiply about patients unable to receive the latest treatment due to a lack of a particular drug. Surgeries have to be postponed when there is not enough supply of a critical drug on hand, leading to increased patient risk and cost. In mid-2014, a shortage of saline, a very common drug, caused delays in many critical procedures in hospitals around the country.

Saline is a simple drug by itself, but it requires stringent manufacturing procedures to ensure that it is sterile. FDA inspectors found such nasty things as bacteria, mold, and glass particles when inspecting units of saline.

While drug manufacturers are often hesitant to criticize the FDA, there are some that feel that the inspection process has gotten so cumbersome that it is getting in the way of efficient and safe manufacturing.

For its part, the FDA has recognized that not all violations affect the safety of the product and the public and is applying more leeway in deciding when to shut down a facility. Where the infraction is in such areas as a minor mislabeling or in having all the necessary paperwork on file, the FDA employs regulatory discretion in deciding which infractions present a risk to patients versus a minor regulatory infraction.

Not surprisingly, some blame the reimbursement policies of Medicare and insurance companies for creating shortages by making the manufacturing of some drugs not economically viable for the pharmaceutical companies. The drug companies are motivated to maximize profit for their shareholders, not to provide a public service.

The public perception of pharmaceutical companies has fallen in recent years. One survey reported that only 34 percent of the public felt that large pharma companies did an “excellent or good” job. There is a growing feeling that drugs are overpriced and that there is too great an emphasis on profits. The greater this public perception becomes, the greater the likelihood of increased governmental pressure and regulation.

There is widespread agreement that improving and streamlining quality control systems in pharmaceutical manufacturing is in everyone’s best interest. Suggestions range from changing corporate culture towards greater acceptance of the FDA quality metrics. At the same time, the FDA is being encouraged to work towards a more standardized set of review procedures that avoids production halt for procedural violations as compared to substantive ones.

While none of these steps are likely to fully resolve the problem of drug shortages, it is encouraging that there appears to be increasing recognition that it is a problem which requires a solution.