JD Journal » Food and Drug Administration

FDA Aims to Shut Down One Man Sperm Bank

rebneely — Fri, 23 Dec 2011 17:03:13 +0000

Tis’ the season for giving. And Trent Arsenault is taking that quite literally.

He is a one man ‘bank’ – a sperm bank, that is. He has a website that lists his education and employment information, as well as his hobbies. In addition, he gives his blood type, as well as medical information, including test results from his most recent sexually transmitted diseases screenings.

No, you didn’t stumble onto one of the lost Maury episodes.

That’s right. Arsenault has been on a charitable mission since 2006, and has been giving away his sperm for free, so as to spare those trying to conceive the exorbitant fees charged by traditional sperm banks.

Since he’s been in the giving mood, Arsenault has fathered fourteen children, and there are four more on the way. He executes written donor agreements with his recipients and delivers his sperm in what he says are sterile storage cups.

That’s all well and good, or is it? The U.S. Food and Drug Administration aims to shut him down, on the grounds that he’s breaking the law by ignoring agency regulations covering those who “manufacture” human cells or tissues. The FDA served him with an “order to cease manufacturing” in November 2010. Specifically, the FDA claims, Arsenault has failed to adequately meet its requirements related to testing donors for communicable diseases.

However, Arsenault is challenging the order and has filed with the agency seeking a hearing on the matter. He argues that his relationship to those to whom he gives his sperm is that of a “sexually intimate partner” and that his donations are therefore not subject to FDA regulations. The case is still under consideration by the FDA, and he is being represented pro bono in his petition by lawyers from Washington, D.C.–based nonprofit public interest group Cause of Action.

Amber Taylor, who joined Cause of Action as a senior attorney in June after three years as an associate at Weil, Gotshal & Manges, authored the group’s November 7 brief backing Arsenault’s petition seeking a hearing.

She was quoted as saying in the recent amlawdaily.com article: “We took up the Arsenault case because we saw it as an instance where the government was improperly applying some regulations, and stepping between two individuals who were trying to have a child. We’re a little concerned when the government is telling people what kind of relationships they have.”

FDA guidelines do not actually define sexually intimate partnerships. That, the Cause of Action brief notes, is evidence that such relationships are defined on an individual basis.

Cause of Action’s brief also seeks to counter a motion to deny Arsenault’s bid for a hearing that FDA staffers filed in February. The agency argues in the order that his sexually intimate partnership claim is merely “an attempt to skirt the law.” Taylor says an evidentiary hearing is necessary to determine whether or not Arsenault’s claim holds water.

Taylor, who spent two years as an associate at O’Melveny & Myers before joining Weil in 2008, says Cause of Action contacted Arsenault in October to offer its assistance.

Gibson Dunn Launches New FDA Practice

rebneely — Fri, 16 Dec 2011 08:00:19 +0000

Gibson, Dunn & Crutcher LLP has announced that Stephen Payne has joined its Washington, D.C. office as a partner.

Payne will help lead Gibson Dunn’s FDA and Health Care compliance and enforcement practice, focusing on pharmaceutical and medical device clients. With Payne’s arrival, the FDA portion of the practice is new to the firm. Payne’s own practice will focus on the representation of pharmaceutical and medical device clients. Payne joins from Sidley Austin, where he was also a partner.

Daniel Nelson, Co-Partner in Charge of the Washington, D.C. office, was quoted as saying in a press release at the firm’s website: “We are delighted to welcome Steve to the firm. His addition will bring a new dimension to the firm’s enforcement practice and will enhance our ability to serve our clients in the pharmaceutical, medical device and health care sectors.”

Andrew Tulumello, Co-Partner in Charge of the Washington, D.C. office was quoted as saying: “Steve is a dynamic and talented lawyer. He has an extensive track record of efficiently obtaining government declinations for clients, and his experience dealing with the FDA and state and federal health care regulators and enforcers on complex regulatory issues will be a great asset to our life sciences practice.”

Payne was quoted as saying: “I am excited to join the firm. Gibson Dunn’s preeminent litigation platform is the ideal foundation on which to build an enforcement-focused practice in the FDA and health care space.”

Payne concentrates his practice on FDA and health care compliance, enforcement, and litigation for pharmaceutical and medical device clients. He has extensive FDA and health care regulatory and compliance counseling experience in the areas of good manufacturing practice regulations, product recalls, product promotion, and fraud and abuse. He has handled criminal and civil investigations conducted by the FDA Office of Criminal Investigations and the Department of Health and Human Services Office of Inspector General, civil False Claims Act qui tam suits, investigations and litigation conducted by state Attorneys General, and other inquiries and litigation relating to health care fraud and abuse and the enforcement of FDA regulations. In addition, Payne has also led internal investigations and compliance audits concerning good manufacturing practice regulations and pharmaceutical promotional practices, including potential off-label promotion and anti-kickback issues.

Payne practiced with Sidley Austin since 2000. Before working in private practice, he served as Senior Trial Counsel for the U.S. Army Judge Advocate General’s Corps at Fort Benning, Georgia and as a Special Assistant U.S. Attorney in the Middle District of Georgia. In 1996, he graduated from Yale Law School. There, he was a John M. Olin Fellow in Law and Economics and a prize finalist in the mock trial competition.

Founded in 1890, Gibson, Dunn & Crutcher is a global law firm with nearly 1,000 attorneys and over 2,000 staff located in 17 offices around the world, including North and South America, Europe, Asia, and the Middle East. In 2010, American Lawyer named Gibson Dunn the “Top Litigation Department” of the year. Among the firm’s most well-known attorneys and alumni are former United States Solicitors General Theodore Olson and Ken Starr, Eugene Scalia, and Miguel Estrada.

Obama Administration’s Top Health Official Blocks Plan B Pill From Becoming OTC

rebneely — Thu, 08 Dec 2011 14:19:59 +0000

Yesterday, Health and Human Services Secretary Kathleen Sebelius – the Obama administration’s top health official stopped the Plan B morning after pill from being allowed to be sold over the counter. Her decision overrules scientists at the Food and Drug Administration.

At the moment, the only people who can purchase the Plan B pill are those aged 17 and older – and can prove it – and who have a prescription.

Sebelius said, per the December 8^th foxnews.com article, “Block of OTC morning-after pill sparks debate”, that “she was worried about confusing 11-year-olds.”

For over ten years, the debate about making access to pills for pregnancy prevention easier has raged on. However, Sebelius’s decision comes with election year consequences. Per the article, her decision caught women’s health advocates off guard. This faction is considered a major part of President Barack Obama’s Democratic base. In addition, many major doctors’ groups disagreed with the decision, arguing that over-the-counter sales could lower the nation’s large number of unplanned pregnancies.

Obama spokesman Nick Papas was quoted as saying: “Secretary Sebelius took this action after careful review. As the secretary has stated, Plan B will remain available to all women who need it, and the president supports the secretary’s decision.”

Dr. Robert Block of the American Academy of Pediatrics was quoted as saying: “Sebelius’ decision is “medically inexplicable.”

In addition, AAP member Dr. Cora Breuner, a professor of pediatric and adolescent medicine at the University of Washington was quoted as saying of the decision: “I don’t think 11-year-olds go into Rite Aid and buy anything, much less a single pill that costs about $50.”

She was also quoted as saying, in regard to making Plan B pills available OTC that they would help those “who have made a serious error in having unprotected sex and should be able to respond to that kind of lack of judgment in a way that is timely as opposed to having to suffer permanent consequences.”

However, conservatives praised the decision.

Wendy Wright, an evangelical activist who helped lead the opposition to Plan B was quoted as saying: “Take the politics out of it and it’s a decision that reflect the concerns that many parents in America have.”

Sen. Chuck Grassley, R-Iowa was quoted as saying: “This is the right decision based on a lack of scientific evidence that it’s safe to allow minors access to this drug, much less over-the-counter.”

FDA Commissioner Dr. Margaret Hamburg was quoted as having written: “There is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

The emergency contraception battle will continue to rage on. Per the article, in 2009, a federal judge said the FDA had allowed politics, versus science, drive its initial behind-the-counter age restrictions and said it should reconsider. At a hearing scheduled in federal court in New York next week, the Center for Reproductive Rights will argue the FDA should be held in contempt.

Use of the Plan B pill within 72 hours of rape, condom failure or merely not using a contraception method reduces the chances of becoming pregnant by nearly 90 percent.

Merck Pays $950 Million in Vioxx Settlement, Settles Criminal and Civil Charges

rebneely — Wed, 23 Nov 2011 12:12:38 +0000

Pharmaceutical giant Merck will pay $950 million, and has pleaded guilty to a criminal charge regarding the marketing and sales of the painkiller Vioxx, both the company and the Justice Department announced in recent days.

The negotiated settlement includes the resolution of civil cases, and marks the latest in a series of fraud cases brought by federal and state prosecutors against major pharmaceutical companies.

Vioxx was approved by the Food and Drug Administration in 1999, then pulled off the market in 2004 because evidence showed it posed a substantial heart risk. In that amount of time, an estimated 25 million Americans had taken the drug.

Under the terms of its plea agreement with the U.S. government, Merck will plead guilty to a misdemeanor for its illegal promotional activity and will pay a $321.6-million-dollar criminal fine. It is also entering into a civil settlement agreement under which it will pay about $628.4 million dollars to resolve additional allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety.

In a statement on Tuesday, Merck said it had previously disclosed the seven-year investigation by the U.S. attorney in Massachusetts and had charged $950 million against its earnings in October 2010.

It marks the latest big payout by a drug company to settle health-care fraud allegations.

Other big payouts by major drug companies include GlaxoSmithKline PLC’s recent agreement to pay $3 billion dollars to settle U.S. allegations of improper drug marketing. Pfizer Inc., Eli Lilly & Co. and AstraZeneca PLC also have reached costly settlements in recent years.

Tony West, assistant attorney general for the Civil Division of the Department of Justice, was quoted as having said in a statement, per the xinhuanet.com article, “Merck agrees to pay $950 million in Vioxx settlement”, “As this plea agreement and civil settlement make clear, we will not hesitate to pursue those who skirt the proper drug approval process and make misleading statements about the safety and efficacy of their products.”

The criminal charges against Merck relate to the company’s misbranding of Vioxx by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration (FDA). Under the provisions of the U.S. Food Drug and Cosmetic Act, a company is required to specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses. This includes any use not specified in an application and approved by FDA, unless the company applies to the FDA for approval of the additional use.

The FDA approved Vioxx for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.

However, Merck said Tuesday the settlement does not mean it admits liability or wrongdoing.

Merck General Counsel Bruce Kuhlik was quoted as having said in a statement: “We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx.”

Sheller, P.C. Primary Counsel for Largest Pharmaceutical Civil Settlement in U.S. History

joshua — Tue, 27 Apr 2010 21:08:55 +0000

According to today’s press release at PR Newswire, AstraZeneca must pay the federal government $520 million in civil fines to settle charges of off-label marketing of the antipsychotic drug Seroquel.

The settlement is the largest pharmaceutical civil settlement, and among the top five civil and criminal drug company settlements in U.S. history.

The U.S. Food and Drug Administration approved Seroquel only for schizophrenia and specific types of bipolar mania. AstraZeneca was charged with promoting Seroquel to physicians for “off-label” use in children and the elderly.

The first complaint was filed in 2004 on behalf of a whistleblower by qui tam whistleblower, class action, and mass tort attorney Stephen A. Sheller, Esq. of Philadelphia’s Sheller, P.C.

The Sheller firm has represented whistleblowers in cases that have resulted in $4.2 billion in settlements for the U.S. government in just the last year and a half.

Sheller, P.C. is among the preeminent plaintiff and qui tam whistleblower law firms in the United States. Founded in 1977, Sheller, P.C. attorneys have litigated groundbreaking cases dealing with everything from tobacco company fraud and consumer electronics fraud to racial discrimination and birth defects.

Covington & Burling Hires More Bush Lawyers

Erik Even — Thu, 07 May 2009 16:35:51 +0000

Covington & Burling, which likes to hire former Republican bigwigs, is bringing on two more Bush administration veterans.

The firm is bringing on George Frampton, former chairman of the White House Council on Environmental Quality, as senior counsel in New York; and Gerald Masoudi, former chief counsel of the Food & Drug Administration, as a partner in Washington, DC.

Covington & Burling LLP is an international law firm with offices in Beijing, Brussels, London, New York, San Francisco, Silicon Valley, San Diego, and Washington, DC. It consistently ranks among the top 20 on The American Lawyer’s prestigious “A-List.”