FDA Policy/General

Look at FDA Enforcement and 1st Amendment: MIWG

In an amicus brief filed with a Massachusetts federal court, the Medical Information Working Group asks that the court address concerns that FDA enforcement policy is not consistent with 1^st and 5^th Amendment principles that permit manufacturers to engage in truthful and non-misleading communications about product off-label uses. The brief was filed in United States v. Facteau to support the defendant’s motion for a judgment of acquittal or a new trial, according to a blog post by attorney Lisa Baird (Reed Smith).

The case involves an executive of the Johnson & Johnson subsidiary Acclarent who, along with another executive, was indicted on 10 counts of introducing adulterated or misbranded medical devices into interstate commerce, one count of conspiracy, three counts of securities fraud, and four counts of wire fraud. The government charged that the executives schemed to fraudulently drive up Acclarent revenues and stock valuation by marketing the Reliva Stratus Microflow Spacer for uses not cleared or approved by FDA. A whistleblower claimed that the company marketed the sinus device for a drug delivery use not approved by FDA. The whistleblower suit was settled by J&J for $18 million two days after a federal court jury acquitted the executives of felony charges but found them guilty of misdemeanor charges of introducing adulterated or misbranded medical devices into interstate commerce.

The brief says that the unclear rules that characterize the regulatory framework and the government’s expansive and ad-hoc approach to enforcement provide inadequate notice of the line between permissible and impermissible speech and, as a result, manufacturers’ constitutionally protected speech is chilled, Baird writes.

She suggests that the brief will be a “useful resource for anyone addressing off-label promotional issues, regardless of whether those involve alleged regulatory violations, as with the criminal prosecution in Facteau or allegations of tort liability in civil litigation.”

In a related development, FDA will hold an 11/9-10 public hearing on “Manufacturer Communications Regarding Unapproved Uses of Cleared Medical Products.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome