Our Broken System: Modifying the U.S. Pharmaceutical Regulatory Scheme to Decrease Surging Prescription Drug Prices

By Dan Gutt

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The pharmaceutical industry’s societal purpose is to improve the health of the citizenry. However, the industry is beginning to fail that purpose by producing expensive prescription drugs, which are becoming inaccessible to the average person. Pharmaceutical prices began to spike in 2014, and there is no evidence that this trend will abate in the future. The causes of this phenomenon stem from several factors: expensive patented drugs, a reduction in the supply of generic drugs, and the pharmaceutical industries large marketing and sales expenditures. In summation, this is a complex problem that cannot be solved by a single solution, nor can it be solved by cost covering measures. Instead, innovative solutions that target the root causes of spiking pharmaceutical prices need to be applied. Examples of these solutions include governmental bulk-buying power, longer patent terms, referencing pricing for patented drugs, and improved FDA … Read the rest

When to Disclose Data Breaches under Federal Securities Laws

By Steven Wittenberg

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Hacking and cybercrime are on the rise.[1] From 2013 to 2015, twenty major data breaches were reported at Fortune 100 companies.[2] Publicly traded companies who have securities disclosure obligations should be aware of their duties under the federal securities laws when it comes to data breaches and hacks.[3]

In 2011, the SEC Division of Corporation Finance issued guidelines for cyber incidents.[4] The SEC stated, “[A] number of disclosure requirements may impose an obligation on registrants to disclose such [cyber] risks and incidents,” although there are no explicit requirements referring to data breaches.

While major data breaches may be material to reasonable investors of public companies, there is no duty to promptly disclose the occurrence of cyber incidents unless there have been selective disclosures, previous misstatements or circumstances making the omission of the hack misleading.[5] The federal securities laws … Read the rest

New York’s Legally Dubious and Harmful Sodium Labeling Scheme

By: Joseph Zender

In September, New York City’s Board of Health (“Board”) passed an ordinance that requires restaurants to post warnings on items on their menus that are have high sodium content.[1] The National Restaurant Association is challenging the new law in state court on the grounds that it is overly burdensome and that it circumvents the legislative process.[2] The new law would require restaurants with more than 15 locations nationwide to place a black triangle next to any item on their menu that contains more than 2,300 milligrams (0.08 ounces) of sodium.[3] Not only is the New York City Board of Health’s move legally dubious by circumventing the legislative process and overly burdening the restaurants, it will also have unintended consequences that will affect the community at large in adverse ways.

The sodium posting requirement is reminiscent of another action by the Board back in 2012, … Read the rest

23andMe: Regulating the Snake Oil Salesman

Crowds would gather when the snake oil salesman came around.1 His magical elixir could cure many ailments, from headaches to kidney problems.2 Before anyone realized that the cure-all was nothing more than mineral oil, the peddler was long gone with their money.3, 4 One of the more famous snake oil salesmen, Clark Stanley, made quite a name for himself in the early 20th century – enough to attract the government’s attention.5 In 1917, federal investigators seized his product, and upon finding that it was not what it claimed to be, Stanley was fined under the Pure Food and Drug Act.6 When the government exercised this FDA-precursor’s power, snake oil sales likely took a turn for the worse.7

The FDA is still cracking down on what it deems to be “snake oil salesmen” in the modern day. Most recently, the FDA has brought this charge … Read the rest

The Overreach of the E.P.A.: Fact or Fiction?

 

 

            Earlier this month the House Energy and Commerce Committee passed a bill, the “Energy Tax Prevention Act of 2011,” which, if it becomes law, would effectively halt the Environmental Protection Agency’s proposed program to regulate greenhouse gas emissions.  This is one of many attempts in an ongoing campaign by Republicans to limit the power of the EPA to make and enforce regulations related to greenhouse gas emissions.  They are attempting this through budgetary control measures as well as by attempting to strip the EPA of its regulatory authority in this area through legislation. There appears to be an intentional effort to cast this as a battle between the legislative and executive branches.  However, this is actually a battle royal including all three branches of the federal government, as well as many state, local, and private organizations.  It is important to look at the recent history of this fight … Read the rest

Regulatory Takings in Real Property: Fact or Fiction?

We are constantly changing the fundamental character of property ownership in this country.  Nowhere is this more evident than in the real property arena. As the past few years have shown us, real estate has morphed from a long-term, stable investment to become a hugely derivative enterprise, which has diversified and become interconnected with other sectors of the economy as never before.  The argument has been made that real estate has lost its original character and that it has become commoditizedRegardless of one’s position on this question it is clear that because of this continual transformation, takings law is constantly pressured to look at situations where the new concept of economic devaluation of property must be reconciled with the traditional notion of the bundle of sticks, and the state’s inability to render that bundle obsolete by legislative action, without compensation. Herein lies the basic regulatory takings Read the rest