Singularity Health Law Blog

CAN THE FDA REGULATE YOUR STEM CELLS?

In July, 2012, Rosemary N, Collyer, a United States District Court Judge for the District of Columbia, ruled that autologous stem cells re-injected into a person’ body following a acculturation of the cells with the use of another drug product shipped in interstate commerce is a “drug” subject to regulation by the U.S, Food and Drug Administration. The purpose of the re-injection is to stimulate the regrowth of bone, cartilage and other human tissue to regenerate them in lieu of joint transplants and other orthopedic surgical procedures.

 

THE NEW ANTITRUST FRONTIER: “WAXMAIL?”

First, there was blackmail, then there was greenmail, and now there is "Waxmail", a new form of extorted payments arising from the dark corners created by the Hatch-Waxman Act also known as the Drug Price Competition and Patent Term Restoration Act. The original purpose of H-W was to provide incentive for generic drug manufacturers to challenge weak patent claims by pharmaceutical companies by providing an exclusive 180 day right of challenge to the first generic company to raise a challenge to a pharmaceutical patent prior to its expiration. As an unintended consequence of the Act, generic companies are settling their patent suits for multi-million dollar payments that provide that the generic companies will sit on their generic products without bringing them to market for an agreed upon period of time. These are called "reverse payment" agreements. Most federal courts of Appeal to have reviewed these agreements have found them not to constitute violations of the Federal Trade Commission Act, contra to the position taken by the FTC, as long as the time of deference did not extend beyond the scope of the face of the patent.

 

“OFF LABEL” DRUG PROMOTION CONVICTION VIOLATES 1ST AMENDMENT

160 Common U.S. Food and Drug Administration (“FDA”) approved drugs which are used for “off label” purposes represent approximately 21 percent of all prescriptions in the United states. Physicians may prescribe FDA approved drugs for any therapeutic use that is appropriate in their medical judgment. The FDA, however, prohibits pharmaceutical companies and their employees from promoting the use of FDA approved drugs for “off label” use. Although there is no express prohibition in the Food Drug and Cosmetic Act or its regulations prohibiting the promotion of drugs for off label use, the government uses a criminal statute which prohibits the introduction of “misbranded” drugs into interstate commerce ( 21 U.S.C. 331(a) and 333(a)(1) to prosecute pharmaceutical companies, their employees and sometimes physicians who are “promoting” the off-label use of drugs.

 

UTAH PRESCRIBES NEW PRESCRIBER LIABILITY DUTY

The Utah Supreme Court last month held that a prescriber of drugs has a duty to third parties injured by the conduct of the patient following the consumption of the medication.  In the case of B.R., a Minor Child and C.R., a Minor Child, through their Conservator, William M. Jeffs v. Trina West, Hugo Rodier and John Does I-X, (Utah, 2012), the Court overturned a lower court dismissal of a case for lack of duty.  The Plaintiffs are the two surviving children of David Ragsdale, who killed their mother after taking the medication prescribed by Ms. West, a nurse practitioner.  The drugs prescribed were Concerta, Valium, Doxepin, Paxil, pregnenelone and testosterone.

$2M RETALIATION VERDICT FOR CARDIOLOGIST UPHELD

The First U.S. Circuit Court of Appeals has upheld a $ 2 Million Dollar Jury Verdict in favor of a San Juan Puerto Rico Cardiologist who claimed he had been retaliated against for filing an age discrimination case five years earlier.  In actual fact, the plaintiff Dr. Munoz was fired within days of giving a deposition in the case wherein he recounted his evidence. The defendants appealed on the basis that the decision to fire him had been made well before his deposition and could not be the basis for establishing a retaliation claim under the Age Discrimination Act of 1967 (ADEA), 29 U.S.C. Section 623 d. The Court agreed, to a point, but found that the retaliation could relate back to the original filing, given other facts.

 

OVER THE COUNTER "DAY AFTER" DRUG: LOOSES TO UNDER THE COUNTER POLITICS.

Plan B One Step a controversial morning after drug that has been the subject of much litigation has been adjudged by the overwhelming majority of qualified reviewers at the FDA as being safe for women of all ages in an over the counter capacity. It is currently available OTC to women 18 years and older. Even that has been continually opposed by certain politicians who consider the drug an anti-abortion drug, which it is not. Access to the drug OTC has been obstructed in the past by interference by the Bush White House and Senior FDA officials.  In 2009, Hon.Edward R. Korman, a federal judge in New York, in the case of Tumino et al. v. Torti,  ordered the FDA to undertake a further review of providing access to women under 18 after finding a history of political interference with the FDAs findings. The FDA recently signaled its intent to offer OTC access to Plan B for all women, but today in steps Secty. of Health and Human Services, Katherine Sibilius to derail the plan claiming that more research is needed.

 

FDA “OFF LABEL” DRUG PROMO BAN UNCONSTITUTIONAL?

Physicians are legally free to use drugs approved by the FDA for one purpose for another purpose in the treatment of patients. In fact,some “off label” uses of FDA approved drugs represent the “standard of care” in the treatment of certain conditions.

On the other hand, pharmaceutical companies are banned under Sec. 331(a) and (k) of the Food, Drug and Cosmetic Act (“FDCA”) from advertising or otherwise promoting an off label use of a Drug approved under the FDA’s New Drug Approval process. In the case of United States v. Alfred Calonia, 576 F. Supp. 2d 385 (EDNY, 2008) Judge Vitaliano denied Mr. Calonia’s First Amendment motion to dismiss a criminal action against him for promoting the off label use of Xyrem, even though the judge determined that the off label use of the drug was not illegal and the representations of Mr. Calonia were neither false nor misleading. Now following Mr. Calonia’s conviction, the Pharmaceutical industry is mounting a full scale charge on the FDA ban, pushing for the Supreme Court to take the case to determine the constitutionality of those provisions of the FDCA.

 

SCARCE DRUG RESELLERS: HEROS OR VILLAINS?

There is a growing “grey market” for critical drugs in short supply.  According to the FDA the shortage of the supply of drugs the absence of which creates the potential for patient harm has tripled in the past five years. Many of these drugs are essential for the treatment of various types of cancers.  There has arisen a group of companies that appear on the surface to profiteering from the shortage by cornering a market on the scarce drugs and demanding and receiving a ransom in payment. Some payments have been as much as 80 times the base price. According to a survey undertaken by the American Society of Health System Pharmacists, over half of the hospitals and medical centers in the country have experienced drug shortages that have affected patient care.

 

THE DOCTOR WHO WILL SEE YOU NOW COULD BE A NURSE.

The New York Times reported today that there is a growing number of nurses who are obtaining clinical doctorates in nursing and representing themselves as “doctors” to the chagrin of some physicians. This year there are some 153 nursing schools in the United States that will extend some 7,037 doctorate degrees in nursing. The physicians apparently see the potential for confusion among patients and the erosion of the status of being called “doctor.”  Some physicians cling so closely to the term that they loose their identity without it.  It is if they received the name “doctor” as their given first name. How many times has one been self introduced to a doctor who says “Hello, I am Dr. Smith.”  There are some women married to physicians who refer to and address their husbands as “doctor.”

 

BRITS SAY MARGINAL LUPUS DRUG TOO EXPENSIVE.

Benlysta is a new Lupus drug developed by Human Genome Sciences and marketed by GaxoSmithKine.  It is the first new Lupus drug to come along in 50 years.  The others are aspirin approved in 1948 and Plaquenil, a malaria drug, and corticosteroids approved in 1955.  A United Kingdom regulator in Britain recommended that the health care system in Britain not pay for the drug because it is too expensive and marginally effective. The cost of the drug in the United States is about $35,000. per year.  In Britain, where big Pharma is a lot friendlier, it is about $15,600.