May 17, 2016 - Bill of Health

FDA Gets Serious about Regulating E-Cigarettes

May 17, 2016May 17, 2016 cguo Leave a comment

Last Tuesday, FDA published in the Federal Register the final version of its “Deeming Regulation.” The final rule, like the proposed rule, subjects all tobacco products to FDA regulation. Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), a “tobacco product” is “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.” The final Deeming Regulations gives FDA control over previously unregulated products such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, hookah tobacco, and gels. FDA’s proposed rule had provided an option that would have exempted premium cigars from regulation, but FDA’s final rule adopted the broader option, subjecting all cigars to FDA regulation.

The 499-page rule responded to a number of challenges posed to FDA’s regulation of previously unregulated tobacco products. Many of these challenges were directed at e-cigarettes (“electronic nicotine delivery systems,” or “ENDS”). FDA responded to these challenges by articulating its view of its authority to regulate ENDS. Specifically, FDA believes:

E-cigarette regulation will benefit the public health, though it is unclear whether e-cigarettes benefit the public health

FDA’s authority to regulate ENDS does not require the agency to establish that regulating ENDS will benefit the public health. The ENDS industry had argued that FDA was required to quantify the health risks of certain products before subjecting them to regulation. FDA argued that section 901, which gives FDA authority to deem products, did not have a public health standard. Read More

The Importance of Transparency in Scientific Innovation

May 17, 2016May 17, 2016 kkwong Leave a comment

The health technology company Theranos once received enthusiastic media coverage for its promises of radical innovation in clinical laboratory testing and its eye-catching valuation of $9 billion. Now the company can’t seem to stop the unending stream of bad news. In addition to Theranos’ previous troubles (discussed here and here), the company is now under investigation by both the U.S. Securities and Exchange Commission and the U.S. Attorney’s Office for the Northern District of California. Recently, Sunny Balwani, the company’s president and chief operating officer, departed Theranos.

Many of Theranos’ problems ultimately reflect systemic issues within medical technology innovation. Multiple articles have begun to discuss Theranos as a cautionary tale for innovators and investors. With the advantages of hindsight, a clear theme emerges from the morass Theranos finds itself in: the company’s lack of transparency about its science is at the root of many of its problems. Theranos’ refusal to allow scrutiny about its science and claims prevented effective oversight and earlier checks on the company’s grandiose claims. This negatively impacted the company’s relationships with regulators, its own board, and its business partners, and has dramatically undermined the company’s claims.

What to Expect When You’re Expecting at Least Another Year of Contraception Litigation

May 17, 2016May 17, 2016 glipper 1 Comment

Photo: Zubik Rally — Tim Ritz/Americans United for Separation of Church and State

By Gregory M. Lipper

In a unanimous, unsigned order hailed as “an almost hilariously brazen punt,” the Supreme Court sent Zubik v. Burwell and the other contraception cases back to the lower courts for further consideration. The order states that, in light of the supplemental briefs submitted at the Court’s request, the parties should have “an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage.’”

That, of course, describes the current accommodation, which the Court in 2014 touted as a compromise that protected women’s interests while relieving religious objectors’ of any burdens created by the previous requirement that they provide and pay for the coverage themselves. But the Court, likely split 4–4 on whether even that accommodation complies with the Religious Freedom Restoration Act, wants the parties to see if they can compromise further without subjecting women to second-class care.

These cases will almost certainly return to the Supreme Court, which may or may not have nine members by that time. But in the meantime, things are up in the air—especially for affected women:

1. The Court decided—nothing. Although objectors’ lawyers claimed victory, even the most nimble of advocates would struggle to identify an actual victory from an order that “expresses no view on the merits of the cases.” Lest any misunderstanding persist, the Court reiterated that it took no position on any of the underlying legal questions:

In particular, the court does not decide [1] whether petitioners’ religious exercise has been substantially burdened, [2] whether the Government has a compelling interest, or [3] whether the current regulations are the least restrictive means of serving that interest.

Those questions will be decided again by the Courts of Appeals, all but one of which has already ruled against the objectors. A victory this is not.