FEDERAL REGULATORY READING LIST: Resources for New FDA Drug and Device Regulators

FDAThe Food and Drug Administration (FDA) faces a difficult balancing act in its role as the federal regulator of drug and medical-device manufacturers.  On the one hand, it is charged with ensuring that medical products are both safe and effective for their intended uses.  On the other hand, it must avoid imposing overly stringent regulations, lest it harm public health by blocking or delaying access to life-saving products, or to truthful information about those products.

Through its public-interest litigating, publishing, and communications capabilities, Washington Legal Foundation has long been at the forefront of efforts to ensure that FDA maintains the proper balance.  Those activities have generated an impressive body of material that would be instructive for new FDA leadership to review.  We provide a summary of and links to those documents below (limited to WLF’s FDA-related work product in the past several years) to simplify access to that work product. Continue reading

Update: Colorado Sues Boulder County Over Divergent Oil and Gas Regulation

coloradoagA February 8 post, Kudos to Colorado AG for Rebuking Boulder County on Its Fracking Moratorium, discussed a letter Colorado Attorney General Cynthia H. Coffman sent to the Boulder County Board of County Commissioners warning that the state would file suit if the county did not end its moratorium on new oil and gas development permits by February 10.

After giving the Board four extra days to comply, Attorney General Coffman filed suit against Boulder on February 14. The suit alleges that the moratorium conflicts with the Colorado Oil and Gas Conservation Act. The state supreme court held in a 2016 decision that the Act preempted anti-fracking rules adopted by two other Colorado localities.

The complaint can be viewed here. Upon filing suit, Attorney General Coffman stated:

The Boulder County Commissioners responded [to the Attorney General’s letter] that they needed yet more time to draft regulations and prepare to accept new applications for oil or gas development.  Because five years is more than reasonable time to complete such a project, and because Boulder County continues to operate in clear violation of Colorado law, the Attorney General today is filing suit in Boulder County District Court to compel compliance.  It is not the job of industry to enforce Colorado law; that is the role of the Attorney General on behalf of the People of Colorado.  Regrettably, Boulder County’s open defiance of State law has made legal action the final recourse available to the State.

Kudos to Colorado AG for Rebuking Boulder County on Its Fracking Moratorium

coloradoagIn the last several years, municipal and county governments have thrust themselves into some of the nation’s most contentious legal-policy debates by imposing regulatory mandates and restrictions on business conduct. New York City famously tried to shrink soda serving sizes. San Francisco has dictated that ads for “sugary drinks” include health warnings. Philadelphia has prohibited businesses from asking job applicants about their salary history. And numerous cities and counties have enacted restrictions or bans on oil and natural gas extraction from shale plays within their borders.

That last type of local regulation has instigated many battles between city or county government and state lawmakers. The latest fight—between the State of Colorado and the County of Boulder—is about to come to a head. In a January 26 letter sent to Boulder County’s three commissioners, Colorado Attorney General Cynthia H. Coffman has given the county until Friday, February 10 to rescind its “moratorium” on accepting new applications for oil and gas development. If the county fails to act, Attorney General Coffman has pledged to file suit. Continue reading

A 2017 Food-Court Resolution: End Regulation-through-Litigation Crusade Against Trans Fat

Partially hydrogenated oil chemical structure

Partially hydrogenated oil
chemical structure

In 2016, class-action lawsuits alleging that a processed food product or its labeling violated state consumer-protection laws continued to clog the federal courts, especially in California. The number of new food-related consumer class actions filed last year nearly equaled the number filed in 2015, according to a report in Food Navigator USA. It’s unclear whether these trends will hold in 2017, but there is one set of blatantly frivolous claims that should disappear this year: those that seek judicial regulation of products that contain partially hydrogenated oil (PHO), the main source of trans fat. A December 13, 2016 Southern District of California decision should frustrate such claims in the short term, and a forthcoming US Court of Appeals for the Ninth Circuit decision in a pending case may (and should) end them permanently. Continue reading

Federal Court in NY Cites Obstacle Preemption in Dismissing State-Law Fraud Suit Against Organic Producer

Cruz-Alvarez_FFeatured Expert Contributor — Civil Justice/Class Actions

Frank Cruz-Alvarez, a Partner in the Miami, FL office of  Shook, Hardy & Bacon L.L.P. with Ravika Rameshwar, an Associate with the firm.

On August 23. 2016, the US District Court for the Eastern District of New York dismissed a class-action suit that alleged the makers of Similac® Advance® Organic Infant Formulas fraudulently misrepresented the products as “organic,” holding that the state claims are preempted by federal law—specifically, the Organic Foods Production Act of 1990.  Marentette et. al. v. Abbott Laboratories, Inc., 2016 WL 4444787 (E.D.N.Y Aug. 23, 2016).  The court stated that Congress designed the OFPA to create a national standard for organic labeling that would be “disrupted, if not thwarted,” by inconsistent state and federal court decisions.  Marentette, 2016 WL 4444787, at *8. Continue reading

Update: Activists Hostile to Domestic Energy Development Fail in Colorado Ballot Initiative Effort

natural gasIn an August 26, 2016 Washington Legal Foundation Legal Backgrounder, Fighting the Frack Attack: The State of State Preemption Efforts, Kelley, Drye & Warren LLP attorneys Wayne D’Angelo and Travis Cushman document how the highest courts in four states have addressed local government limits on highly successful oil and gas extraction methods, such as hydraulic fracturing and horizontal drilling. The most recent state court to consider the issue, the Colorado Supreme Court, held that two local governments’ limits on extraction techniques conflicted with the state’s oil and gas regulatory regime.

The paper noted that at the time of its release, it was unclear whether the Colorado Supreme Court’s rulings would remain in force because “Colorado is at the epicenter of a heated ballot initiative to change the state’s oil and gas laws.”

The Denver Post reported August 29 that the sponsors of two ballot initiatives related to oil and gas extraction failed to collect the number of requisite signatures for a November 8 vote. One measure would have prohibited new oil and gas facilities within 2,500 feet of homes; the other would have expanded local governments’ authority to restrict hydraulic fracturing. The Colorado Secretary of State’s random sampling of signatures for the two initiatives not only showed that their sponsors came up short of the 98,492 needed, but also that some of the signatures may have been forged.

Activists hostile to domestic energy development also failed in 2014 to place similar measures before Colorado voters.

Update: FCC Declines Appeal of Sixth Circuit Loss in Municipal Broadband Preemption Case

FCCThe Federal Communications Commission (FCC) announced on August 29 that it will not be appealing its loss in the US Court of Appeals for the Sixth Circuit in Tennessee v. FCC. The August 10 decision held that FCC lacked the authority under Telecommunications Act § 706 to preempt state limits on municipalities’ offering of broadband services. Washington Legal Foundation supported the Petitioners in the case with an amicus brief on which we represented former FCC Commissioner Harold Furchtgott-Roth.

FCC argued that § 706 granted the Commission broad public-interest authority to dictate how states regulated the activities of their own local towns and cities. Tennessee and North Carolina both permit municipalities to offer government-owned broadband services, but they limit the offering of those services to the municipalities’ geographical borders. The Commission acknowledged it could not prohibit states from banning municipal broadband, but asserted that once states allowed such services, § 706 empowered FCC to preempt state policies that stood “as a barrier to infrastructure investment and broadband deployment.”

As former Commissioner Furchtgott-Roth and his Hudson Institute colleague Arielle Roth explained in an August 18 WLF Legal Pulse post, “The Sixth Circuit correctly rejected FCC’s basis for preempting the North Carolina and Tennessee statutes, stating that nowhere in § 706 did Congress indicate an intent to preempt internal state laws governing broadband deployment.”

The extent of FCC’s overreach was made manifest last November when the Department of Justice declined to sign FCC’s Sixth Circuit brief. Experts noted at the time that DOJ’s absence conveyed a not-so-subtle message to the Sixth Circuit. The Sixth Circuit sent an even clearer message to FCC with its August 10 decision, one that the Commission finally appears to have received.