Recently in Government Relations Category

In December, a Second Circuit Court of Appeals decision on off-label use promotions made life less complicated for pharmaceutical sales reps in New York, Vermont, and Connecticut. The appellate court ruled that a drug manufacturer’s off-label use promotions are protected free speech, as long as such promotions are not false or misleading.

The 2-1 majority reasoned, “In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed.”

There is a limit to the government's patience after all.

Tuesday, the Supreme Court announced in Sebelius v. Auburn Regional Medical that hospitals can't rely on equitable tolling to extend the time limit for appealing Medicare reimbursements. Instead, they must discover and appeal federal underpayments within three years of receiving a Notice of Program Reimbursement (NPR).

In a unanimous decision, the Court held that the Secretary of the Department of Health and Human Services (HHS) could limit the time for a Provider Reimbursement Review Board (PRRB) appeal to three years. The Court also concluded that the presumption in favor of equitable tolling does not apply to administrative appeals of the kind here at issue.

That means that in house counsel for Medicare providers must act quickly to correct the government's errors.

What's going on with the Federal Trade Commission's Google antitrust investigation?

Commission officials piqued the industry's curiosity last week when they announced that they had hired litigator Beth A. Wilkinson to assist in the investigation. The Paul Weiss partner is a former Justice Department prosecutor, and some have compared her hiring to that of David Boies when the government sued Microsoft.

Others just see it as proof that the FTC is prepared to litigate should Google not bend to its terms.

Regulators worldwide issued more than 14,000 regulatory announcements in 2011, up 16% over 2010 -- and the number will likely rise again in 2012, a new report finds.

The 14,215 regulations announced worldwide in 2011 amounted to about 60 regulatory changes per workday, according to the "State of Regulatory Reform 2012" report by Thomson Reuters Governance, Risk & Compliance.

Global businesses are struggling to keep up with the regulations which affect companies' bottom lines and the global economic recovery, the report states.

Non-lawyer investors for law firms might be more prevalent in the future.

Jacoby & Meyers, the New York personal injury firm, has filed a lawsuit against the state. They are trying to overturn the rule that prohibits non-attorneys from owning interests in law firms.

Some attorneys are against this shift, including Robert Weber, senior vice-president for legal and regulatory affairs and general counsel of tech giant IBM.

In perhaps the largest drug settlement to date, GlaxoSmithKline PLC has announced that it will pay the federal government $3 billion.

The Glaxo settlement will cover a number of ongoing federal civil and criminal investigations. These include allegations that the company engaged in the off-label marketing of Wellbutrin; downplayed the risks of Paxil and diabetes drug Avandia; and defrauded Medicaid.

After a decade of high-profile violations of food and drug laws, the Food and Drug Administration appears to be reviving the 1943 Responsible Corporate Officer Doctrine, holding executives responsible for illegal conduct that may have occurred without their knowledge.

Limited to misdemeanor convictions, these new regulators are also seeking to exclude these executives from participating in a variety of government programs, effectively ruining their careers.

Oh, and they're going after the lawyers, too.

Returning to wrap up business after last week's bankruptcy announcement, Solyndra executives were surprised to find federal agents executing search warrants issued by the Department of Energy's Office of Inspector General.

A spokeswoman for the FBI, who confirmed that the Bureau is acting in partnership with the Department of Energy, declined to explain the purpose of the Solyndra raid, indicating that the documents are under seal.

Solyndra executives have also been left in the dark.

Former General Counsel Russell Mackert of A&O Resource Management, Ltd. was sentenced to 15 years and 8 months late last month for his role in a scheme that defrauded elderly investors of $100 million.

Along with four other A&O executives, Mackert was accused of making material misrepresentations to investors, misusing investor funds, smuggling cash, and committing mail fraud.

He pled naiveté.

Though the FDA is downplaying its request that Pfizer re-submit thousands of adverse event reports, according to a study done by the non-profit Institute for Safe Medication Practices (ISMP), the manufacturer's lack of compliance with reporting rules hid 150 Chantix suicides.

The catch? The majority of those suicides occurred prior to 2009, when Chantix became affixed with the agency's strict "black box warning."