As a patent is about to expire, generic drug makers can request FDA approval for their drug if it is a bioequivalent of the patented version. The brand-name companies obviously do not want the generic drugs to be approved because they will lose money.
One way companies have found to delay the release of generic drugs is through “citizen petitions”. These petitions allow anyone to express safety concerns about a drug and request that their information be further investigated. Citizen petitions delay the approval of generic drugs because the FDA has to decide whether they will look into the petitions concerns’ about the generic drug..
The brand-name companies generally file the petitions for the FDA to look over when the brand-name drug is set to expire, which is when the generic companies are seeking approval. No petition that was filed on the eve of a generics’ approval has been approved. During one dispute , U.S. magistrate Judge Rosalyn Chapman said to one drug company about it’s petition, “This is all about money…Maybe they think I think it’s about safety, but I think it’s all about money.”
If the company is successful in delaying the release of the generic drug for only a few months, the drug company has still made millions of dollars from exclusive sales of their drug.
For example, in 2005, one month before Mylan Laboratories Inc. was expected to launch sales of a generic version of Alza Corp.’s Ditropan XL, an incontinence treatment, Alza filed a citizen petition challenging the generic. Although the FDA ultimately gave final approval to Mylan, the delay gave Alza months of exclusive sales at an estimated $1.8 million daily.
Congress wants to impose new reforms to stop manipulation of “citizen petitions”, but some think that the contentious litigation will remain a problem for years because of the large amount of money at stake. Next year over $29 billion worth of drugs will no longer be patented, and billions of dollars more the next few years.
The U.S. Senate last week inserted petition reforms in a major FDA overhaul bill. The measure would not allow a petition to delay FDA approval of a generic unless delay is necessary to protect public health. As a check on competitors, petitioners must verify who is making the challenge and whether they expect to be paid for filing the petition. Congress must get annual reports on delays to generics based on the petitions.