Light Finally Shining on FDA’s Approval Delays of Next-Generation Sunscreen Products

sunshineGuest Commentary

by Samantha J. Malnar, a 2014 Judge K.K. Legett Fellow at the Washington Legal Foundation and a student at Texas Tech School of Law.

A “call to action” this week from the Surgeon General of the United States reports that nearly 5 million people are treated with skin cancer in America each year. Of those treated yearly, 9,000 die from melanoma. The report explains that skin cancer is the most preventable form of cancer, and urges steps government and individuals can take to reduce the risks. Regretfully, the Surgeon General failed to spotlight the role government regulation has played in increasing the risk of skin cancer. Thanks to federal regulators’ unconscionably slow action on reviewing and approving new formulas, Americans can only get the best available sunscreens overseas.

It has been fifteen years since the Food and Drug Administration (FDA) has approved a new sunscreen ingredient, even though there are eight applications pending—some dating back to 2002. Notably, the last application was submitted in 2009, which suggests that the agency’s failure to act has deterred companies from investing in the United States market. As the former head of the American Academy of Dermatologists told The Washington Post, “These sunscreens are being used by tens of millions of people every weekend in Europe, and we’re not seeing anything bad happening.” In fact, in European countries, sunscreen manufacturers can choose from twenty-seven chemicals, seven of which were specifically designed to protect against UVA rays.

As of right now—as was the case fifteen years ago—sunscreen manufacturers in the U.S. are limited to the use of seventeen sunscreen ingredients, only three of which protect against UVA rays. UVA rays are especially dangerous because they deeply penetrate the skin, normally damaging it without showing any immediate signs or symptoms of the damage, such as sunburn. Continue reading

FDA Advisory Committee Not Rife with Conflicts of Interest? — “Please!” Quips Federal Judge

FDAIn order to achieve results that it believes are vital to public health, the Food and Drug Administration (FDA) has demonstrated time and again that it’s not afraid to trample laws and constitutional rights along the way. Occasionally, judges reintroduce FDA to the Rule of Law. We applaud one such recent rebuke by Judge Richard Leon, whose July 21 Lorillard v. FDA decision reminded FDA that it cannot stack a science advisory panel with members who will tell the agency what it wants to hear.

FDA tobacco control. After the U.S. Supreme Court rejected the agency’s attempt to seize regulatory oversight of tobacco products in 2000 (FDA v. Brown & Williamson), Congress granted FDA the authority it coveted in 2010. Banning or severely restricting the use of menthol in cigarettes has long been a goal of FDA’s friends in the anti-tobacco movement. FDA created a science advisory panel, the Tobacco Products Scientific Advisory Committee (TPSAC) to study menthol. The TPSAC concluded in 2011 that menthol had a negative effect on public health. Two companies filed suit in Febuary 2011, charging that FDA violated federal law by appointing members to the TPSAC who had clear conflicts of interest. The plaintiffs asked the court to strike the TPSAC’s report from the regulatory record.

Judge Leon’s opinion. The TPSAC members in question had ongoing contracts to testify as expert witnesses for plaintiffs in suits against tobacco companies. They also served as consultants to manufacturers of tobacco cessation products. FDA didn’t feel such relationships conflicted with their duties on the TPSAC. Judge Leon was quite flabbergasted by FDA’s decision. “Please!” he exclaimed, adding, “This conclusion defies common sense.” With regard to the members’ work with plaintiffs’ lawyers, Judge Leon explained that they had a financial incentive not to make any recommendations that would compromise the lawsuits in which they would testify. On the product consulting work, the judge noted that any FDA regulation of menthol would likely inspire more smokers to quit, potentially with the assistance of cessation products. Thus the TPSAC members also had a financial incentive to offer advice that would encourage a ban or restrictions on menthol. Judge Leon concluded that such blatant disregard for obvious conflicts violated federal law, and he enjoined FDA from utilizing the report in its assessment of menthol. Continue reading

Fifth Circuit Puts an End to Texas Pharma Plaintiff’s California Dreamin’

laskerGuest Commentary

By Eric G. Lasker, Hollingsworth LLP (Mr. Lasker argued McKay on behalf of Novartis Pharmaceuticals Corporation in the Fifth Circuit)

Debates over whether—and in which circumstances—Food and Drug Administration (FDA) approval of prescription drugs and medical devices should preempt State law have been in the forefront of Supreme Court jurisprudence and Congressional action for over a decade. However, when a State itself concludes that FDA approval is the correct standard for state law liability, one would think that would end the debate, right? Well, yes, but not without a few tantrums along the way.

Texas’s FDA Defense. In 2003, Texas enacted a tort reform statute which protects pharmaceutical products manufacturers (subject to specifically defined exceptions) from liability based upon a warning or other information that was approved by the FDA. Tex. Civ. Prac. & Rem. Code § 82.007(a). Texas took this step based upon the Legislature’s informed view that the State was facing an environment of excessive litigation that had caused a crisis in access to healthcare. Of course, the plaintiffs’ bar argued strenuously to the contrary. Many of their brethren appeared in hearings before the Texas Legislature; they accused the Legislature of caving to “Big Pharma” and argued that the FDA couldn’t be trusted to review drug safety. But the Legislature disagreed, and FDA-approval was adopted as the presumptive standard of care in pharmaceutical products liability cases in Texas.

Plaintiffs’ Bar’s Efforts to Judicially Nullify § 82.007(a). What was the response? Predictable. The plaintiffs’ bar turned to the courts to undo what the Legislature had done. They argued that § 82.007(a) should be read narrowly to apply only to expressly-labeled “failure to warn” claims, ignoring the fact that in pharmaceutical litigation, the adequacy of warnings is key regardless of the legal theory of liability. They argued that a jury should decide whether § 82.007(a) even applied, seeking a threshold whereby the jury could decide that the manufacturer secured regulatory approval through fraud on the FDA—despite clear U.S. Supreme Court authority that such a state law jury inquiry was preempted by federal law. They argued that the entire statute should be stricken if their interpretation of the fraud-on-the-FDA exception to § 82.007(a) was not accepted.

Thus far, each of these arguments has been rejected. As a result, one Texas plaintiff recently took a step that many Texans would consider a sacrilege: he asked the court to treat him as a Californian instead! The case is McKay v. Novartis Pharmaceuticals Corp., and on May 27, 2014, the United States Court of Appeals for the Fifth Circuit rejected this desperate gambit as well. McKay v. Novartis Pharm. Corp., __ F.3d __, No. 13-50404, 2014 WL 2198544 (5th Cir. May 27, 2014). Continue reading

Solicitor General’s Brief in Medical Device Tort Case Capitulates to Plaintiffs’ Bar

DOJThe Obama Administration has been a faithful friend of the plaintiffs’ bar, particularly regarding federal preemption of State-law tort claim against product manufacturers. The Food and Drug Administration has, for example, proposed a regulation (with direct input from plaintiffs’ lawyers) on labeling of generic drugs that would sweep away a federal preemption defense upheld twice by the U.S. Supreme Court.

A Supreme Court brief filed on May 20 by the Solicitor General of the United States provides another example of just how committed the Administration is to this mutually beneficial friendship. In urging the Court to deny review in a medical device preemption case, the brief urges the Court to ignore an express preemption statute and to effectively overrule its 2008 pro-preemption decision in Riegel v. Medtronic.

The Supreme Court has steered a middle course when previously considering claims that the federal statute at issue, 21 U.S.C. § 360k(a), preempts product liability suits against medical device manufacturers. It held in a 1996 case that federal law does not preempt claims involving the vast majority of medical devices: those devices being marketed based on a determination that they are “substantially equivalent” to devices already on the market as of 1976 (so-called § 510(k) devices).   The Court explained that FDA never undertook a formal review of the safety and effectiveness of such devices, and thus there was no reason to believe that Congress intended to prevent States from imposing their own safety and effectiveness requirements. The Court later held in Riegel that § 360k(a) generally does preempt design defect and failure-to-warn claims involving the small number of Class III devices that FDA has approved for marketing following a safety and effectiveness review undertaken in accordance with the agency’s rigorous pre-market approval (PMA) process.

The Solicitor General’s office submitted its brief in connection with a petition (Medtronic v. Stengel) seeking review of a U.S. Court of Appeals for the Ninth Circuit decision that claims involving a PMA device for delivering pain medication were not preemped. (WLF filed an amicus brief in support of certiorari). Riegel left open the possibility that some State law claims might escape § 360k(a) preemption if they were “parallel” to federal law; i.e., if the State were simply imposing the very same requirements on a device that FDA regulations specific to the device already imposed. Lower courts have struggled in the ensuing years to craft a workable definition of a “parallel claim,” and the Stengel petition asks the Supreme Court to resolve a well-entrenched conflict among the federal appeals courts regarding the meaning of the parallel-claims exception. Last October, the Supreme Court invited the Solicitor General to comment on the petition. Continue reading

Update: Two Food Labeling Suits Settle after Judge Certified Narrowed Classes

kellogg'sLast November, while assessing several losses by plaintiffs in “all natural” food labeling class actions, we discussed two opinions issued by the same Southern District of California judge (Marilyn Huff) on the same day (July 30, 2013). Both opinions certified far narrower classes of plaintiffs than the lawyers in each case sought.

The defendants in these cases—Bear Naked and Kashi (both owned by Kellogg’s)—unsuccessfully sought the U.S. Court of Appeals for the Ninth Circuit’s permission to immediately appeal Judge Huff’s certification orders. With Kellogg’s facing trial in both cases, albeit against smaller classes of plaintiffs, it entered into negotiations which resulted in proposed settlements to be presented to Judge Huff in consecutive hearings on May 27. We describe the proposed settlements below and offer some thoughts on them.

Astiana v. Kashi Company. Frequent plaintiff Skye Astiana, who complained in a suit against Ben & Jerry’s that the company’s alleged mislabeling of its ice cream “disrupted my vibe,” will be $4,000 richer thanks to the proposed settlement’s “incentive award” for the named plaintiffs. The company is creating a settlement fund of $5 million, out of which the incentive awards will be paid, as will the $1,250,000 in attorneys’ fees and costs. What will the “absent” class members recover? That depends on the proof they offer. Those with proof of purchase can recover $.50 for each item, with no limit on the total amount of recovery as long as receipts are presented. Those with no proof of purchase can file claims for $.50 per item with a maximum recovery of $25. In addition, Kashi will remove from certain products’ labels and advertisements the terms “All Natural” and “Nothing Artificial.”

Thurston v. Bear Naked. The proposed settlement terms in Thurston largely mirror those in Astiana. The named plaintiffs are to receive $2,000 incentive awards. The settlement fund is $325,000. Absent class members with receipts can receive $.50 for each product with no maximum recovery limit. Those who can’t prove they purchased the supposedly offending Bear Naked products can claim $.50 for each item with a $10 maximum. Bear Naked agrees to remove “100% Natural” and “100% Pure and Natural” from its labels and ads. And the attorneys’ fees? The Class Counsel will only be seeking “an award of reasonable, actual out-of-pocket expenses.” Why so modest? Many of the same law firms which sued Bear Naked were also counsel to the Astiana class. Because Thurston and Astiana involved nearly identical issues, it’s doubtful that Judge Huff would award substantial fees for the law firms’ work in Thurston. Continue reading

Update: After Being Steeped in Criticism, FDA Signals Change on Brewers’ Spent Grains

spent brewing grains

spent brewing grains

Last week in FDA’s Proposed Regulation of Brewers’ Spent Grains is All Wet, we explained the deep flaws in the Food and Drug Administration’s proposed application of the Food Safety Modernization Act to the by-products of brewing, distilling, and winemaking when those spent grains and grapes are sold or donated to farmers for livestock feed. We certainly weren’t alone in finding the proposal deeply misguided and entirely counterproductive to other goals such as environmental sustainability, local sourcing, and reducing food prices.

It seems the cacophony and the diversity of voices expressing their disapproval got through to the leadership at FDA. Politico Pro reported in its Morning Agriculture email blast this morning that New York Senator Chuck Schumer had received a call from FDA Commissioner Hamburg assuring him that changes were coming. Sen. Schumer’s office put out this statement. Also, in an April 24 FDA Voice blog post, “Getting It Right on Spent Grains,” Deputy Commissioner for Food Dr. Michael Taylor (who, we noted in our post last week, assured House members FDA would not “impose [food safety] regulations for the sake of regulating”) wrote “we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it.”

We applaud FDA’s willingness to see reason and admit error here, though we remain puzzled as to how the proposal came about in the first place.

we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it. – See more at: http://blogs.fda.gov/fdavoice/index.php/2014/04/getting-it-right-on-spent-grains/#sthash.4Tpo3vZV.dpuf
we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it. – See more at: http://blogs.fda.gov/fdavoice/index.php/2014/04/getting-it-right-on-spent-grains/#sthash.4Tpo3vZV.dpuf
we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it. – See more at: http://blogs.fda.gov/fdavoice/index.php/2014/04/getting-it-right-on-spent-grains/#sthash.4Tpo3vZV.dpuf

FDA’s Proposed Regulation of Brewers’ Spent Grains is All Wet

spent brewing grains

spent brewing grains

During his February 5, 2014 appearance at a House Energy and Commerce Committee hearing, Food and Drug Administration (FDA) Deputy Commissioner Michael Taylor stated that “the whole goal of [the Food Safety Modernization Act (FSMA)] is to achieve the food safety goal without imposing regulations, just for the sake of regulation.” Dr. Taylor must have been unaware of his agency’s proposal to require that brewers, distillers, and vintners develop extensive hazard analysis and control plans before selling or donating their spent grains or grape pomace to farmers for livestock feed. This proposal seems to be the epitome of regulating for the sake of regulating.

Farmers have been procuring and feeding their livestock spent brewing grains and grapes for centuries. These livestock “happy hour” arrangements advance environmental sustainability, engender bonds among local businesses, and financially benefit both parties. Farmers get low cost whole grain feed packed with fiber, protein, and, of particular importance to livestock in arid climates, moisture. Alcohol makers save millions by not having to landfill the by-products.

FSMA Section 116 exempts activities at facilities which “relateto the manufacturing, processing, packing, or holding of alcoholic beverages.” In a proposed animal food safety regulation, FDA essentially nullifies this statutory exemption. The agency “tentatively concludes” that when brewers or distillers go through the “mashing” process—soaking grains in hot water—and then offer the by-product to farmers, they suddenly become food producers. The same goes for winemakers and their grape pomace. FDA’s conclusion has sparked a deserved firestorm of opposition from the affected industries as well as members of Congress. Continue reading

WLF Briefing Discusses FDA’s “Plaintiffs’ Bar Over Patients” Generic Drug Labeling Proposal

FDA’s Generic Drug Labeling Proposal: Unauthorized and Counterproductive Disturbance of the Hatch-Waxman Balance

Our Panelists

  • Ralph G. Neas, The Generic Pharmaceutical Association
  • Alex Brill, American Enterprise Institute
  • Richard A. Samp, Washington Legal Foundation

Accompanying Materials

 

Update: FDA Drags Feet on Approval of Internationally-Accepted Vaccine While Drexel Student Dies of Meningitis B

Drexel University

Drexel University

The Centers for Disease Control and Prevention (CDC) have concluded that a Drexel University student who died in early March was infected with the same strain of meningitis, “serogroup B,” that some Princeton University students contracted in late 2013. The two schools are separated by about an hour in the greater Philadelphia area.

We discussed the outbreak at Princeton, as well as another one at the University of California Santa Barbara, and the need for those schools to “import” a meningitis B vaccine from overseas, in a December 19 post, The Meningitis B Outbreak: Heavy Doses of Government Can Be Costly. The vaccine had to be imported under an emergency exception because the Food and Drug Administration (FDA) has still not approved its use in the United States.

The situation at Drexel could parallel the developments at Princeton as opposed to those at UCSB. The Drexel student was reportedly in contact with Princeton students who had visited her at Drexel just a week before her death. In response, Princeton, which obtained and administered Novartis’s Bexsero vaccine after a lengthy federal government-required process, will be offering another round of vaccinations next week. News reports do not indicate whether the Princeton students in contact with the deceased Drexel student had received the inoculations that were made available on their campus, but only 80% of Princeton students have received both recommended doses of vaccine. One hopes that any students who bypassed the inoculations last time around have learned their lesson and will take full advantage of the next round of inoculations being offered.

Meanwhile, students at Drexel and their families will have to be satisfied with CDC’s conclusion that because there are no other meningitis B cases identified at the university, “members of the Drexel community are not considered to be at increased risk.”  Continue reading

FDA Action Should Take the Juice Out of Some Food Labeling Class Actions

Unevaporated Cane

Unevaporated Cane

We admit that before scrutinizing the related wave of food labeling class action litigation, we had never seen the term “evaporated cane juice” (ECJ).  It might be fair to wonder whether many of the plaintiffs in these suits had ever noticed it on food labels either. But claims alleging that using ECJ on a food label violate federal rules (and thus also California law) have become ubiquitous. As of January 22, there were over 50 suits pending in federal courts with an ECJ claim. Thanks to an action yesterday by the Food and Drug Administration (FDA), those claims may not survive beyond March.

FDA formally reopened the comment period for draft guidance first published on October 7, 2009. That draft guidance informed industry that “dried cane syrup,” not evaporated cane juice, is the common or usual name under federal rules for “the solid or dried form of sugar cane syrup.” FDA never finalized that guidance, but true to FDA form, the agency still invoked it in warning letters sent to companies using the term evaporated cane juice. Continue reading