Last Updated May 28, 2010 10:57 AM EDT
The bottom line: The days of generic drug companies printing money by simply photocopying other companies' drugs may be over. They're going to have to get into the postmarket safety surveillance business, too.
There's a caution here for consumers, too: While the government and the media may be urging you to choose generic products in light of the Tylenol recall, bear in mind that even though the generics are supposed to be identical to the real thing, they're actually not tested for safety before they reach the pharmacy shelf. (The law just assumes that because they're identical, they're safe.)
The case is a heartbreaker. Katelyn Weilbrenner of Moultrie, Ga., went to see her doctor about acne, and he prescribed minocycline, an antibiotic based on Lederle Labs' Minocin brand. Pretty soon she got severe headaches and, before she stopped taking the medicine, she'd lost almost all her sight. Weilbrenner's doctor testified in a deposition that he had no idea the drug was associated with blindness in teens, and that he would not have prescribed it had he known that.
Teva did know of an association, Weilbrenner alleged, but didn't do anything about it:
Defendant has admitted it was aware of the reported association between the use of minocycline and the potential development of pseudotumor cerebri in adolescent patients well before the incident leading to Ms. Weilbrenner's permanent loss of vision.
Nevertheless, Defendant also admits it has never mailed any information to any physicians in the United States informing them of this association, nor advised them of the need to routinely check patients for papilledema (i.e., swelling of the optic nerve, a hallmark of PTC) while taking minocycline.
Moreover, Teva has not undertaken to provide such information to physicians since this incident causing legal blindness to Ms. Weilbrenner.Teva argued that it copied the Lederle warnings as required by law:
Federal regulations require that the product labeling for Teva's generic drug minocycline be identical in all material respects to that of its reference-listed drug MinocinÂ®, thus dictating the precise warning language that had to accompany the product that Ms. Weilbrenner allegedly ingested. Federal regulations prohibit Teva from making any changes to the labeling that would cause it to diverge from the FDA-approved MinocinÂ® labeling, under threat of removal of Teva's product from the market.But recent cases, including another Teva case from 2007 in a Massachusetts state court (Kelly v. Teva), have found that generic companies have the same duties as regular drug companies: They must file label updates if new risk information emerges.
Of course, this may all change if the U.S. Supreme Court rules that its earlier preemption ruling in Wyeth v. Levine (which found that state drug laws are not preempted by the more minimal federal standards) does not extend to generic companies.
- Wyeth v. Levine's Unintended Consequences: Prescription Data-Mining Banned in Vermont
- CA Supreme Court: Wyeth Liable Even Though Patient Never Took the Drug