Introduction

In a drug recall, the manufacturer of a prescription drug or over-the-counter medicine takes its product off the market. Sometimes the U.S. Food and Drug Administration (FDA) requests the recall, while at other times the manufacturer initiates the recall. Either way, the FDA plays a key role in the process. Pfizer, one of largest pharmaceutical companies, announced on January 31, 2012, a voluntary nationwide recall of Lo/Ovral®-28 (branded) and Norgestrel/Ethinyl Estradiol tablets (generic) due to inconsistencies in the drug and out of sequence tablets.

Background

Pfizer is one of many pharmaceutical companies racing to reinvent itself after facing patent loss of blockbuster drug Lipitor and the recall of birth control pills. When people think of Pfizer, trust and brand loyalty come to mind.

Lo/Ovral-28 contains a combination of ethinyl estradiol and norgestrel that is used as contraception to prevent pregnancy. The drug recall affects 14 lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets. The contraceptive pills are all marketed in the U.S. by Akrimax Rx Products and are manufactured by Pfizer. The oral birth control products use a series of 21 active drug tablets and 7 inactive sugar/placebo tablets to regulate the menstrual period while providing contraception. Contraception may be significantly weakened if the sequence of birth control pills is out of order. Pfizer found an issue with some packets of the drugs having too many tablets, with others having too few. The problem was caused by both mechanical and visual inspection failures on the packaging line.

Issue

Is the pharmaceutical company Pfizer’s reputation in jeopardy after recalling 1 million birth control packs?

Rule

Pfizer will be able to recover their reputation if all of the following conditions are met:

  • They have more stringent quality control on packaging
  • Better inspection before the medication is distributed

Analysis

Pfizer officials stated that as a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception and at risk for unintended pregnancy. These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Consumers trust pharmaceutical companies to give them the correct form of drug. Not having strict quality control on packaging is causing problems over recalls and has drawn attention from lawmakers. CNN notes, “two bills introduced this year would impose stricter regulations on the industry and give the FDA authority to mandate recalls.” One of the biggest issues was packaging. If they had monitored the manufacturing agency closely, 28 lots of birth control pills would not have been recalled, causing them a loss in revenue.

Administering a thorough inspection before the medication is distributed should be enforced aggressively to avoid this type of mishap. Having a recall of 1 million birth control pills that have been distributed to warehouses, clinics, and retail pharmacies nationwide endangers a lot of people. Although the only flaw in the drug is the packaging, and Pfizer stressed that the defects in the packs do not pose any immediate health risks to individuals taking the pill, there is a risk of unplanned pregnancy.

Conclusion

When a person takes medication, they automatically think it’s safe. However, in reality there are flaws associated with drugs. Pfizer’s mechanical failure could leave women at risk for pregnancy due to differences in hormone levels in the pills. One million birth control packs recalled is not a small number; therefore, strict regulations should be enforced adequately when managing quality control, and thorough inspections of drugs should take place before distributing. If this happens, Pfizer’s reputation will be recovered.

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