Monthly Archives: December 2014

Maine Ebola Quarantine Underscores Importance of Due Process during Public Health Emergencies

Although the fervor of domestic news coverage regarding the West Africa Ebola outbreaks has subsided, cases that were treated in the U.S. shed light on a public health infrastructure to which Americans rarely give much thought. Among the discussions of travel bans and increased surveillance, an issue arose of particular legal importance: the quarantine of Kaci Hickox.

Kaci Hickox entered the United States on October 24 after a month of work with Doctors Without Borders treating Ebola patients in Sierra Leone. Per protocols developed by the New Jersey Department of Health (NJDOH), Homeland Security officials detained Hickox upon her arrival at Newark Liberty International Airport. During her detention, her temperature appeared elevated, and, following the protocol, Homeland Security transferred her to a New Jersey hospital for quarantine under the watch of NJDOH. An Ebola test administered at the hospital came up negative. Despite the test results, the NJDOH detained Hickox until October 27, when she threatened legal action against the state. At that point, NJDOH released Hickox, who returned to her home in Maine. After Hickox’s arrival in Maine, the Maine Department of Health (MDOH) sought a court order to enforce a 21-day in-home quarantine against Hickox.

Although the MDOH action was rare, it is hardly unprecedented. Societies reaching back to the middle ages have long sought to isolate citizens in the interest of public health. In the United States, courts have upheld state government efforts to do so, even in certain extreme cases where, in the course of quarantine, citizens have been jailed or had treatment forced upon them.

MDOH moved to exercise its quarantine power over Hickox pursuant to the state’s public health emergency statute. Under that law, MDOH may exercise certain powers—such as supervision or monitoring of a citizens health—if a “public health threat” exists. Such a threat can include “behavior that can reasonably be expected to place others at significant risk of . . . infection with” a communicable disease that is reportable to MDOH.

MDOH grounded its argument for Hickox’s quarantine in the fact that she had been exposed to Ebola while treating patients while in Sierra Leone, that Ebola is a particularly virulent disease, and that, to minimize risk to the public, she needed to be isolated from the public for the balance of the 21-day incubation period during which she might develop symptoms. A day after issuing a temporary order on October 30 granting the MDOH petition, the Court altered its position.

In its October 31 order pending hearing, the Court struck down the quarantine. Citing information presented by MDOH in its petition, the Court noted that, despite her exposure to Ebola, Hickox was not symptomatic and, therefore, did not present a risk of infection to the public; only if she were contagious would the quarantine be justified. With that in mind, the Court permitted Hickox to move freely, but also upheld MDOH’s requests that she submit to direct monitoring for symptoms, coordinate her travel with MDOH, and immediately contact MDOH if symptoms develop. The MDOH monitoring of Hickox ended without fanfare on November 10, the end of the 21-day incubation period. Hickox did not develop symptoms at any point during her monitoring.

As fear about a domestic outbreak of Ebola fades, Hickox’s case serves as a useful reminder of the importance of providing due process to those whose freedom is restricted during public health crises. Aggressive state action may, at times, be informed by public sentiment and fear a threat to safety; judicial recourse must ensure that such action is properly checked and grounded in sound assessments of any risk to public health.

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Rising Pharmaceutical Costs Hit the Generic Market

In 1984, the 98th Congress passed the Drug Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Amendment, creating a statutory scheme wherein generic drug manufacturers will be able to put their products into the market using the pioneer (or branded) drug’s scientific safety and efficacy data. In return, the pioneer manufacturer is awarded five-years of market exclusivity before the generic may enter the market. Congress intended to allow the pioneers to recoup their capital spent on research and development as well as turn a profit, but then have prices decrease dramatically as generics enter the market. It worked as intended! The generic drug industry has been booming since its inception.

However, in recent years, drug prices have been increasing and increasing quickly. In 2013, Tetracycline, an extremely common generic antibiotic that most all of us have likely taken throughout our lives, cost only five cents per pill. In 2014, the very same antibiotic cost $8.59 per pill. This increase constitutes a 17,714 percent jump in just one year! The drastic jump in prices stands in the face of Congress’s intention with the Hatch-Waxman Amendment, but can the increase be explained by the market?

In the cases of Tetracycline, the price jump resulted from a drug shortage. Generic companies lacked the necessary raw materials to produce the drug in significant quantities. The shortage of Tetracycline continued for nearly two years. However, the Food and Drug Administration (FDA) announced that the producers now have adequate materials to produce the drug. There were also manufacturing issues associated with the shortage that have also been fixed.

The larger issue may be the market itself. When an all-star branded drug is on the market, the generic manufacturers line up to enter the market. When four or five generics enter the market, the prices drop significantly. However, without several generics of a single drug on the market, prices do not drop as dramatically. Supplies can drop for any number of reasons. Companies may simply leave the market. An FDA-inspection may lead to a temporary shutdown of a plant. Regardless, less competition means higher prices and, for the consumer, tough choices when it comes to medical care. For example, only three companies currently produce digoxin, a cheap and easy to make cardiac drug that has been around since at least 1785. At the beginning of the year, a month of digoxin cost approximately $50 (one consumer reported $1.15 for a three-month supply), but now customers are seeing prices nearing $1000 per month. Notably, the World Health Organization lists digoxin as an “essential medicine.”

Some voices, however, have expressed concerns about nefarious business practices. In 2013, the Supreme Court ruled that the Government and private parties may sue pioneer companies who pay competitors to stay off the market. The practice has caught the attention of the Federal Trade Commission (FTC) and state officials. An antitrust investigation of Lannett by the state of Connecticut found that the manufacturer had not violated any law or regulation. However, many of these price adjustments happen naturally, leaving the FTC without any options to combat the problem.

The problem has caught the attention of Congress, who requested explanation for drug price increases fourteen drug manufacturers (constituting ten of the nearly 12,000 generic drugs on the market). However, without any legal mechanism to act against the companies, Congress may have few options to deal with the issue. Sen. Bernie Sanders and Rep. Elijah Cummings have proposed a bill to require generic manufacturers to rebate Medicaid if drug costs increase faster than inflation. The CEO of Generic Pharmaceutical Association believes the legislation to be “misguided.” Whether the bill passes or not, it appears to do little to help consumers attain better access to their needed medication. Until action is taken or anticompetitive practices can be definitely proven, more and more patients will have to decide whether they can afford their medication this month.

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