Pfizer Elbows in to Vaccine Data Rollout, Janssen Fights Drug Lawsuit
After a U.S. District Court judge ruled that the U.S. Food and Drug Administration must begin disclosing data surrounding the approval of COVID-19 vaccines within a span of eight months, Pfizer hopes to step in to ensure that no trade secrets are disclosed when the regulatory agency begins to share that information.
According to Reuters, Pfizer's legal team is seeking permission from the court to ensure the FDA does not "inappropriately" disclose any trade secrets or confidential commercial information surrounding the COVID-19 vaccine the company developed with BioNTech. Pfizer said it supports public disclosure of the FDA records in order "to promote transparency and the public's confidence in the vaccine."
The U.S. law notes that government agencies do control the release of information. However, companies can challenge this and even sue to block the disclosure of certain details.
The FDA said in its own filing that it welcomes the opportunity to work with Pfizer regarding the massive information dump that is on its plate.
A hearing is scheduled for tomorrow to consider Pfizer's request.
Earlier this month, U.S. District Judge Mark Pittman overruled the FDA's plan to delay the rollout of vaccine approval data for 55 years. The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to promote transparency of the COVID-19 vaccine data used to secure Emergency Use Authorization.
As Biospace previously reported, Pittman found that the Freedom of Information Act filed by PHMPT "is of paramount public importance." The release of the data is expected to begin in August.
While Pfizer looks to participate in the rollout of FDA data, Johnson & Johnson subsidiary Janssen Pharmaceutical faces a $10 million lawsuit over claims that bladder cancer drug Elmiron caused damage to a patient's eye.
According to the lawsuit, Janssen became aware of reports of retinal damage after Elmiron went on the market in 1996. The case claimed that clinical data from studies that began in 2018 documented a link between Elmiron's key ingredients, pentosan polysulfate sodium (PPS) and a condition known as pigmentary maculopathy. However, the lawsuit claims that no warning label was placed on Elmiron until 2020.
The law firm behind the suit claims that Janssen "looked the other way" when reports of retinal damage associated with long-term use of Elmiron were reported. They claim that the injuries suffered by the plaintiff were preventable.
Furthermore, the firm said that those injuries "resulted directly from defendants' (Janssen's) failure and refusal to conduct proper safety studies, failure to properly assess and publicize safety signals, suppression of information revealing serious risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Elmiron."
There are more than 600 claims against Jannsen related to Elmiron.
Featured Jobs on BioSpace