FDA Deference

Subscribe to FDA Deference via RSS
Photo of Eric Alexander

In our day job, we generally rely on final decisions of FDA about things like drug approvals, device clearances, and rules and guidances.  We also rely on the general integrity of the FDA’s processes.  Even when there are things we do not like on the merits, like observations in form 483s or warnings letters—each is not a final determination of anything according to FDA—we often look to the process itself, which can include a number of steps after the offending statement or action is final.

We also find ourselves calling to the Congressional charge of FDA to protect public health and its various powers of enforcement as counters to the plaintiff charges that FDA’s actions or actions do not amount to condoning our client’s conduct.  Even when we read reports like IOM’s panning aspects of FDA, we still find ourselves looking at the process for the product in our case, with (we hope) thorough evaluation of evidence, layers of review, and consistency in reasoning.

The underlying facts in Ivy Sports Medicine, LLC v. Sebelius, No. 11-cv-1006 (RLW), 2013 U.S. Dist. LEXIS 51763 (D.D.C. April 10, 2013), test even our somewhat slanted view of things.  The case came up on dueling summary judgment motions on an Administrative Procedures Act (APA) review of an FDA decision on a medical device.  We have posted on cases in a similar posture before and noted the tension we, as a drug and device products defense lawyers, feel when FDA screws up.  In Ivy, the court is asked to decide whether FDA has inherent authority to correct what it considered a massive screw-up and whether it behaved rationally—as opposed to arbitrarily and capriciously—in its correction.  In other words, as a big-boned Colorado kid would demand respect for his authority in any situation, is FDA’s inherent authority to be respected when it takes unusual steps to correct a prior abuse of its authority?Continue Reading Respecting FDA’s (Inherent) Authority

Photo of Stephen McConnell

There was much gnashing of teeth among members of the defense bar in the wake of Wyeth v. Levine‘s curtailment of FDA preemption.  It felt like a missed opportunity.   But some of our more persistent and creative colleagues insisted that a lot of the facts and factors we typically seized upon to argue for…

Photo of Bexis

We’ve blogged a lot about implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and in particular how the FDCA expressly bars private enforcement of purported violations of the Act.  That’s good – very good indeed – as far as it goes.  But what’s the point as a practical matter?
We think the point is how preemption protects Congress’ additional decision in the FDCA to grant the FDA almost unlimited discretion to prosecute, resolve, or excuse violations as the Agency sees fit.  Basically, the FDA’s exclusive enforcement authority reinforces those parts of the FDCA that confer upon the FDA the ability to select which violations of the FDCA to prosecute and which to settle administratively.  As the Court observed in Buckman, FDA has “complete discretion” in deciding “how and when [its enforcement tools] should be exercised” and must exercise that discretion “to achieve a somewhat delicate balance of statutory objectives.”  531 U.S. at 348.  Preemption and prosecutorial discretion go hand in hand.
The Supreme Court looked at this interplay some years earlier in Heckler v. Chaney, 470 U.S. 821 (1985), in which death row inmates tried to throw a monkey wrench into their sentences by seeking to force the FDA to prevent the use of certain drugs use in executions.  The FDA had exercised prosecutorial discretion to refuse to enforce the statute in this manner.  The Supreme Court affirmed the FDA’s right to determine for itself how to enforce the Act:

[A]n agency decision not to enforce often involves a complicated balancing of a number of factors which are peculiarly within its expertise.  Thus, the agency must not only assess whether a violation has occurred, but whether agency resources are best spent on this violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits the agency’s overall policies, and, indeed, whether the agency has enough resources to undertake the action at all.  An agency generally cannot act against each technical violation of the statute it is charged with enforcing.  The agency is far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities.

Id. at 831-32.Continue Reading Don’t Forget FDA Prosecutorial Discretion

Photo of Stephen McConnell

Here’s a shocker: your average drug and device law lawyer seldom hoists more weight at any one time than 22 ounces of F.3d or three ounces of The Glenlivet. There is usually a long, nerdy history behind this state of indolence. For example, when we were in high school, we got a varsity letter for…

Photo of John Sullivan
In old movies, everybody seemed to use coffee to sober-up a friend who’d had too much to drink.  (The only other option, if our movie-memory is correct, was a bucket of ice water.)  Do you remember “Dead Men Don’t Wear Plaid” – an old movie about older movies?  Steve Martin played a Sam-Spade-like detective who

…

Photo of John Sullivan
It’s Memorial Day weekend, and it’s time for barbeques.  While many of us will choose an alcoholic drink to enjoy during the festivities, there may be non-alcoholic drinks involved too.  Maybe a nice juice drink.  That usually means grape, apple or cranberry juice, or some combination of them.  Lately some people are even choosing pomegranate

…

Posted in FDA
Photo of John Sullivan
When most of us think of the First Amendment, commercial speech is probably not what springs to mind.  A business talking about its products doesn’t fit our classic perception of free speech.  It will never equal the “I Have a Dream” speech or stir inspiration in your soul.  But it’s important.  It really is.  The

…

Posted in FDA
Photo of Bexis

What does a smokeless “electronic cigarette” have to do with drugs and medical devices?  Well, according to the FDA, an electronic cigarette is a “drug-device combination.”  Lately, however, it seems that the Agency’s position has become a strategic misstep. It gave rise to this a recent opinion by Judge Richard Leon, Smoking Everywhere, Inc. v. …

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book