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.
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.
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.
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.
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.
Recently the FDA requested two of its clinical research committees to determine whether bisophosphonate osteoporosis drug efficacy would benefit from a “drug holiday” in light of concern over the surfacing of unusual side effects. The drugs such as Merck’s Fosamax, Roche’s Boniva, Warner Chilcott’s Actonel and Novartis’ Recloct, are designed to prevent or reduce the impact of osteoporosis in post menopausal women, but there have been disturbing cases surfacing of unusual femur fractures and bone necrosis in jaws related to long term use.
The FTC has dipped its toe in the water of smartphone and ipad technology by announcing that it intends to regulate a “narrow subset” of smartphone medical devices that meet the definition of a “device” under Section 201(h) of the FD&C Act, 21 U.S.C. 321. In a recent news release it indicated that it intended to regulate those applications meeting the definition of device and 1) used as an accessory to an already regulated medical device or 2) that transforms a mobile platform into a regulated medical device. See 76 Fed. Reg. 43689. In its news release the FDA noted a study that indicated that 500 million smartphone users will be using health care applications in the near future. The FDA indicated that it intended to regulate those applications that create great risk when they do not work as intended. An example of a device that would be regulated is a smart phone that is converted to an ECG heart monitor.(i.e. Smartheart, a self service heart monitor).
The U.S. Attorney’s office in Rhode Island and the FDA’s Office Criminal Investigations managed to squeeze a half a billion dollars out of Google for publishing online ads for Canadian pharmacies selling low cost drugs to consumers in the United States. Google had blocked similar ads from other countries, but not Canada. Peter F. Neronha, the U.S. Attorney proudly proclaimed that the investigation and settlement was a significant step in curtailing the activities of “rogue pharmacies” to reach U.S. consumers with drugs that may be unsafe and/or unlawful. Note, he didn’t say “actually unsafe and/or illegal.”
In 2009 the FDA requested the Institute of Medicine (“IOM”), a part of the National Academy of Sciences, to undertake a study of its 510(k) approval process to determine its effectiveness and to make recommendations to improve and strengthen it. It hardly imagined that the recommendation out last week would be to dump it altogether. The 510(k) clearance process for moderate risk devices such as hip replacement devices, external heart defibrillators and hospital based pumping devices provides an easier road for medical device manufacturer’s to obtain regulatory approval of new technological advances in medical devices without going through the more cumbersome, comprehensive and expensive PMA or premarket approval process required for higher risk products.
The recent growth in physician owned distributorships (“PODs”) prompted five U.S. Senators to ask the HHS Inspector General to undertake an investigation to determine if they are in compliance with federal law, particularly the federal anti-kickback statute. This would appear to be almost a foregone conclusion. POD’s provide physicians, particularly surgeons, with another bite in the surgical food chain by permitting them to take a financial cut when a POD provided device is implanted in a patient. Hospitals are generally happy to please their surgical staff by purchasing and stocking the devices preferred by the surgeons. Would it surprise you to learn that there tends to be a strong surgeon preference for devices from the distributorship in which the surgeon has a financial interest?
