More burdens face industry and FDA in wake of ruling

March 11, 2009 – 2:23 pm by Steven Niles

The fallout from the Supreme Court’s Wyeth v. Levine decision will be added burden not just for pharmaceutical manufacturers, but FDA as well, according to Gary Liberson and Craig Wylie in PA Consulting’s Life Sciences & Healthcare practice. Pharmaceutical marketers will be burdened to meet individual State product care laws. Meanwhile, FDA will be faced with a massive new burden to review and approve new labels for existing products.

Mr. Liberson and Mr. Wylie shared their thoughts with me on all the challenges the industry will now face in light of the ruling:

While explicit legislative language gives medical devices protection from state requirements, no such barrier exists for pharmaceuticals. The immediate impact of this ruling is predicable. There will be legislative jockeying to either protect pharmaceuticals or remove the protection from devices. There will be a rash of law suits to test in State courts the boundaries of the ruling. However, these suits will all be for the past. The big question is how can company’s reduce their risk going forward? How do company’s (or the FDA) decide the label does not adequately describe the risks? After all, analysis of this concern has always been part of the FDA review process. This is no easy task – but one that must be addressed.

It is clear that the label that started this suit described the dangers of the treatment. Furthermore, this is not a typical pharmaceutical. It is administered solely by “trained” professionals. Therefore, is the only course of action to use a black label warning (presently the strongest warning that the FDA requires for drugs that may cause serious adverse effects) for situation as this? It can’t be.

State label laws were developed to protect consumers from the dangers of a product. While pharmaceuticals clearly are products, they have two unique characteristics that make State laws ill prepared to create a useful standard. First, pharmaceutical labeling receives stringent FDA review and approval. Furthermore, all medical treatments are a balancing of risks and benefits.

So unlike consumer products where the label is meant solely to describe dangers, how can a patient be properly informed of the benefits? This will all evolve over time – but for now the industry has some serious work before it.

Finally, while the financial burden may now lie with the manufacturer, there is no doubt that the FDA is will be faced with a massive new burden to review and approve new labels for existing products. This new burden will clearly affect the length of time necessary to approve new drugs. Labeling has just become a more complicated process where attorneys, risk assessors, key opinion leaders and the FDA must now decipher the Supreme Court ruling.

Tags: law, Phenergan, Supreme Court, Wyeth