Pfizer Inc. argues it should have a say in a lawsuit seeking information about its COVID-19 vaccine to ensure trade secrets and confidential commercial information are not disclosed.
A group of doctors and scientists sued the U.S. Food and Drug Administration in federal court in Texas, seeking details about the FDA’s licensing of the vaccine. Pfizer’s lawyers told U.S. District Judge Mark Pittman that the company should be allowed to join the case so it can help the FDA avoid “inappropriately” disclosing trade and corporate secrets.
The doctors and scientists who sued the FDA argue it’s too early for Pfizer to join the case because no one is challenging redactions made to the records requested in the lawsuit. The judge has ordered the quick release of hundreds of thousands of documents in the case, noting it’s “of paramount public importance.”
The FDA told the court it believes Pfizer can help the agency navigate the “unusual and indeed extraordinary circumstances of the case.” Government agencies like the FDA control the release of documents under the federal public records law, but companies like Pfizer can challenge and sue to block the release of certain information.
The federal judge will consider Pfizer’s request and is expected to address concerns raised by the FDA about his order to start releasing 55,000 pages of documents monthly in March. The FDA previously proposed releasing 500 pages a month in response to the lawsuit, a schedule that would require more than 50 years to complete. Pfizer argues its intervention in the lawsuit “will help accelerate the release of documents.”
Pfizer stated in its court filing that it supports public disclosure of the FDA records related to its vaccine “to promote transparency and the public’s confidence.”
But lawyers with Siri & Glimstad, a New York boutique firm that filed the lawsuit on behalf of the Public Health and Medical Professionals for Transparency, argued Pfizer doesn’t need the court’s permission to help the FDA. The company can support the agency’s efforts to release the records without intervening in the lawsuit. The lawyers said they wouldn’t fight Pfizer’s intervention if the “involvement is limited to prevent delay or prejudice.”
The battle between the dairy industry and plant-based milk products to limit the legal use of the term “milk”, while perhaps not earth-shaking, is an interesting example of how regulation can be used to clarify and limit the use of terms. And when you think about the business of the law, in reality, that’s what much of it is about. You can’t have regulation and law without a strict definition of many concepts. Food standards of identity (SOI) are requirements by the FDA that do just that.
For an example close to that of the dairy vs. other kinds of milk battle, think of the use of the term “organic.” Often, the legitimate use of that term boosts a product’s value by a substantial amount. But what exactly determines whether a product is organic? A governing body must set the standards to clearly outline what “organic” is considered to be. The USDA does this for many products.
The term “milk” is not problematic in the same way. It’s not as if most consumers don’t realize almond or soy milk are not from cows. They certainly do. We know, for example, that almond milk has nothing to do with bovine lactations, but features a certain type of nut. The fight seems to boil down to a certain type of proprietary value that the dairy industry feels is connected to the term “milk.” And, doubtless, the products produced by those in the plant-based segment of the milk market have converted an increasing amount of dairy-product customers.
Smelling the Roses
Does a rose by any other name really smell as sweet? In this case, the dairy industry seems to say it does not. When governing bodies like the FDA make a determination to limit a term, like “organic”, or “meat” there are usually counterfeit products claiming to be something they are not. But the many non-dairy products that use the term “milk” simply seem to be using the term in a more general, but still accepted, way, similar to the way the term “juice” is used. It’s difficult to say how much economic value use of the term “milk” has. It seems slightly ridiculous to enforce limited usage at this late stage. Still, the final determination on who exactly can utilize the term “milk” hasn’t been made yet, although an upcoming FDA public meeting may do just that.