Caronia- Former Drug Rep

Congratulations to Al, his fine legal team and his family.
Rest in Peace Bill. We are so sorry noone fought for you. We tried and we will continue to try to find out who fatally wounded you that March night in 2006.
Dr. Gleason, Pura Vida. You were a man of amazing grace.
You have been vindicated Dr. Gleason. We wish you could have held on...We will miss you forever.

 

Glad Al hung in there. Didn't know Gleason did this....

The Florida Department of Health is seeking to sanction a doctor who committed suicide in February, distraught over getting swept up in an off-label promotion sting.

Psychiatrist Peter Gleason will be unable to respond to Florida Board of Medicine Case No. 2009-18280, in which the state's Department of Health seeks to discipline the doctor for touting off-label uses of a drug during industry-funded talks in several states years ago. His family says the resulting legal and professional woes, which they argue would have been mooted by the recent Supreme Court decision on prescription data, drove him to hang himself.

Gleason was arrested in 2006, and indicted by a federal grand jury in the US District Court for the Eastern District of New York. He pled guilty to one misdemeanor count of engaging in interstate commerce of a misbranded drug. He received a year of probation and a nominal fine.

“My brother never should have been arrested for speaking truthfully to his fellow physicians about the off-label uses of an FDA approved drug—anywhere or any time,” Sally Gleason Goodson told MM&M by e-mail, referencing Sorrell v. IMS Health, in which the majority concluded that a Vermont statute imposed a burden on protected expression.

“He enjoyed being a speaker for Jazz Pharma; talking about a drug that he truly believed in and used in his psychiatric practice,” Gleason Goodson continued. “The over-reaching powers of a federal prosecutor and the [Department of Justice] led to his suicide after 5 years of their torment.”

 

is there anybody out there
i feel like i'm talkin to myself

 

A shameless New York Federal prosecutor calculated a sleazy scheme to ban constitutionally-protected truthful speech. He excessively abused a company (Jazz Pharmaceutical), a salesman (Al Caronia), and a physician ( Dr. Peter C. Gleason).

Gleason killed himself after the prosecutor spearheaded a five year campaign to obliterate Peter’s professional reputation; tattering his personal pride. This slim-ball’s actions also caused medical licensing problems.

The Gleason Family will forever remember the mourning this dirt-bag has caused. He is wished a lifetime of pain and personal failure.

 

The worsrt part is that this was done in the name of justice. We know that "justice" had nothing to do with this. This and every case like it is done in the name of the almighty dollar$$$. Pursuing cases of off-label promotion has become a multi-multi-million dollar business for the DOJ. I guarantee you they will fight this recent ruling with tremendous vigor.

 

It might serve you well to state only what you know. Speculation and "guarantees" does you and no one else any good. Our "friends" at the DOJ will do their job. Vigor is never for the faint- hearted!

- Jermaine Jazz Jr.
- Dir. Sales/ Op.

 

"A Doctor's Posthumous Vindication" in the Wall Street Journal
December 25, 2012 by Harvey Silverglate
On December 3, a three-judge panel of the U.S. Court of Appeals for the Second Circuit ruled in favor of Al Caronia, a pharmaceutical salesman who had been convicted of violating the Federal Food, Drug and Cosmetic Act by pitching the off-label uses of a narcolepsy drug to doctors at conferences throughout the country. Declaring that the Department of Justice’s overly broad interpretation of the law violated Caronia’s free speech rights, the Court vindicated a practice that has become commonplace among physicians.
Doctors such as Peter Gleason, Caronia’s former codefendant, learn through their experiences with patients that many drugs turn out to be effective treatments for ailments other than those for which the FDA has granted official approval. And physicians have a well-established right to prescribe any drug for any use they see fit and to share their insights about effective treatments with other doctors. So it came as quite a surprise to Dr. Gleason when he was arrested by a half-dozen federal agents one day in 2006 and sent down the rabbit hole of the federal criminal justice system for allegedly conspiring to mislead his fellow physicians. I discussed Dr. Gleason’s unjust prosecution in my book Three Felonies a Day: How the Feds Target the Innocent (Encounter Books, 2009). My latest piece for the Wall Street Journal serves as a postscript for that discussion, explaining how the Second Circuit’s ruling vindicated Dr. Gleason’s belief that he had never engaged in any improper activity – vindication that, tragically, came too late.

You can find the piece on the Wall Street Journal's website

 

Black and Whitey: How the Feds Disable Criminal Defense
Two remarkable legal proceedings are currently wending their way through the federal criminal courts. The cases involve very different parties: Conrad Black, one of the most consequential public intellectuals and businessmen of our era, and James “Whitey” Bulger, a Boston-based alleged racketeer and serial murderer. But both cases highlight some of the same profound problems with the way federal prosecutorial business is done these days.
In both cases, as in countless others, the feds have used certain techniques that virtually assure convictions of both the innocent and the guilty, the wealthy and the poor, the violent drug dealer and the white collar defendant, indifferent to the niceties of “due process of law,” particularly the right to effective assistance of legal counsel. In order to prevent a defendant from retaining a defense team of his choice, federal prosecutors will first freeze his assets, even though a jury has yet to find them to have been illegally obtained. They then bring prosecutions of almost unimaginable complexity, assuring that the financially hobbled defendant’s diminished legal team (or, as is often the case, his court-appointed lawyer) will be too overwhelmed to mount an adequate defense.
Prior to 2004 Conrad Black was a columnist, as well as chairman and chief executive of Hollinger International (now part of Sun-Times Media Group), a newspaper publishing giant whose holdings include the Chicago Sun-Times and the Daily Telegraph. He remains a highly regarded historian and author. In a case of enormous (and unnecessary) complexity, the Securities and Exchange Commission and the Department of Justice went after him on the basis of a dubious and controversial theory that in arranging the sale of Hollinger’s assets, he finagled and structured the deal so as to personally receive a larger share of the proceeds than his ownership percentage entitled him. Rather than test their theory by filing a civil lawsuit on behalf of the minority shareholders, the feds brought an indictment running 75 pages, with 15 complex counts. After many years of litigation and several partially successful trips to the Supreme Court, Black found himself still convicted on two criminal counts, for which he served 42 months in prison.
It is quite possible that Black might have totally prevailed in his case, unnecessarily obscure and complex though it was, had he been able to employ from start to finish his initial legal counsel of choice: the fabled Washington, D.C. firm of Williams & Connolly, which had been representing him with considerable vigor in the pre-indictment stages. But the DOJ did what it routinely does in well-defended cases brought against well-heeled targets: it froze the bulk of Black’s considerable assets, including the $9 million proceeds from the sale of his New York apartment that Black had specifically allocated for his legal defense. Black could no longer fight utilizing his “A” team.
After Black had exhausted his last appeal to the Supreme Court, and after he was finally released from prison, the courts dissolved the asset freeze, and Black found himself once again in a position to employ a top-flight legal team. He and his lawyers-of-choice brought an innovative legal attack on his conviction, claiming that the improper asset freeze had deprived him of the constitutionally-guaranteed effective legal counsel of his choice. To raise the issue at such a late date, Black’s lawyers, the highly regarded Cleveland-based firm BakerHostetler, relied upon an ancient but rarely used common law-based procedure known as a petition for a writ of error coram nobis—the same procedure used in 1983 by Fred Korematsu to declare the World War II relocation of Japanese-Americans (including Korematsu himself) unconstitutional.
Meanwhile, in Boston, Whitey Bulger was having similar problems. A reputed mobster with a long history of violence, Bulger was captured in California in June 2011, rousted from his apartment where federal agents found an arsenal of illegal weapons and $800,000 in cash (which, importantly, had not been traced to any identifiable illicit activity) hidden behind a wall. Bulger was wanted in Oklahoma and Florida state courts for murder. In addition, the federal court in Boston charged him with racketeering, in two separate, sprawling indictments, one from 1994, and one from 1999. The 1999 indictment also subsumed 19 alleged murders.
Without much doubt, the 1999 Boston indictment would have been the most difficult, complex and expensive case for Bulger to defend against. Yet the feds chose to proceed on this case and dropped the 1994 indictment. As with Conrad Black, they froze all of Bulger’s assets, including the cash found behind the wall. Bulger had to satisfy himself with a court-appointed lawyer. It happens that the appointed lawyer was someone of considerable reputation and experience, but the feds neutralized the appointed lawyer’s skill by pouring more than 360,000 pages of disorganized documents onto him.
The federal magistrate and the judge have been very spare in their granting adequate relief to Bulger’s lawyer in terms of time and resources needed to organize and study the mountain of documents. While the Sixth Amendment to the Constitution provides that “the accused shall enjoy the right to a speedy . . . trial,” the courts have twisted the law by claiming that the public, including Bulger’s alleged victims, have a similar right. This, then, is used as an excuse to rush Bulger to trial before his rather skimpy legal team can be fully prepared.
Thus, Bulger will ultimately encounter much the same disability as Black: an inability to put up a fair fight in a case of unnecessary complexity defended against by a legal team inadequately equipped for the task because of a lack of sufficient time and resources.
These techniques are the rule, not the exception, when the Department of Justice really wants to win a case. When federal drug enforcers decide to go after physicians who recommend drugs for the alleviation of chronic pain in quantities or for conditions that roam outside of drug warriors’ notions of the “good faith” practice of medicine, they indict the doctors under statutes aimed at drug dealers, then freeze their bank accounts.
I wrote in my 2009 book, Three Felonies a Day: How the Feds Target the Innocent, about the 2006 prosecution of Dr. Peter Gleason, who was targeted for touting the benefits of the drug Xyrem for a number of medical conditions beyond what the U. S. Food and Drug Administration (FDA) approved. His assets frozen, Dr. Gleason, represented by an appointed Federal Defender, pleaded guilty to a reduced charge in a plea bargain. Gleason expressed anger at having to drop his fight, assuring me of his innocence (assurances I examined and accepted) until February 7, 2011, when, worn out by the battle, he committed suicide. (The U.S. Court of Appeals later ruled, in the case of Dr. Gleason’s co-defendant, that the FDA’s application of its regulations was unconstitutional.)
When corporate executives are investigated and charged, the Department of Justice has been known to pressure their employer corporations to refuse to live up to contractual agreements to pay attorneys’ fees for indicted executives. This practice was immortalized in a series of Department of Justice directives, one of which, signed June 16, 1999, is known as the “Holder Memorandum” in honor of its drafter, the current attorney general, at that time the deputy attorney general in charge of the Criminal Division at the DOJ. (In 2006, United States District Judge Lewis Kaplan in Manhattan declared the DOJ’s practice unconstitutional, a decision affirmed by the Second Circuit Court of Appeals. Judge Kaplan wrote that the corporation only “refused to pay because the government held the proverbial gun to its head.”)
Federal prosecutors, in contrast to most of their targets, operate on the basis of munificent funding (even if the money is borrowed by the government). They invariably have more resources than all but a tiny number of defendants. But this advantage is significantly magnified when a defendant’s assets are frozen just as he seeks adequate and effective defense counsel to handle massive document dumps and overwrought indictments.
Lord Black’s coram nobis petition (his title derives from his membership in the British House of Lords) is being closely followed around the country, as is Whitey Bulger’s more sensational prosecution. Both cases, along with hundreds, if not thousands, of other federal prosecutions currently lodged in the bloated federal criminal justice system, raise the question of whether the federal Constitution, which supposedly guarantees defendants a fair trial, prohibits the feds from bringing unnecessarily complex charges and then financially disabling defendants from engaging in a fair fight. Hinging on the answer to that question is nothing less than a defendant’s chance at an accurate outcome dictated by the facts and the law.
(Mr. Silverglate, a Boston lawyer, is the author of Three Felonies a Day: How the Feds Target the Innocent. The research and editing assistance of paralegals Juliana DeVries and Zachary Bloom is gratefully acknowledged.)

 

IS THIS GUY FO REAL????????????? HE WAS THE PROSECUTOR ON GLEASONS' CASE AND THEN SUDDENLY REPLACED.
Idiot


Philly Pharma

Ultimate impact of Caronia decision uncertain, but FDA and prosecutors might be more careful
POSTED: Friday, December 28, 2012, 8:14 AM
Two former prosecutors say the ultimate impact of the decision in U.S. v. Caronia won't be known until further court action, but in the meantime, former colleagues prosecuting cases might be more careful in forthcoming cases.
But the Dec. 3 opinion also doesn't give a free pass to pharmaceutical companies and their sales reps to say anything about any drug.
"I don't think this opinion is a license to do that," said Geoff Kaiser, who was one of the U.S. Attorney's in Brooklyn who brought the original charges against Orphan Medical, Alfred Caronia and doctor Peter Gleason for off-label marketing. "I don't think it establishes that it's okay for a pharmaceutical company to promote an unapproved indication."
Kaiser was in private practice by the time the charges against Caronia were reduced to misdemeanors, which Kaiser said was a factor in the outcome of the appeals decision. He also suspects that prosecutors have already spent more time searching for evidence of misdeeds before bringing charges, rather than relying on what a sales rep might have said. The majority opinion in Caronia, according to Kaiser, says, "You can't argue that words themselves are the offensive conduct."
It is uncertain if the Supreme Court will get this case.
An Inquirer story on the topic is here.
Virginia Gibson prosecuted cases with the U.S. Attorney's Office in Philadelphia and now is a partner at Hogan Lovells, which has pharmaceutical companies as clients. She said the other day that there is not yet a dramatic change in the FDA drug approval process - or what patients can do.
"I think the Second Circuit decision does not change the safety regime that the FDA runs to protect patients," Gibson said. "Patients now, as before the decision in Caronia, can still ask, 'Did the FDA approve this product for what you're prescribing it for or what you're using it for in surgery?' That is still the case."
Gibson suggested the majority tried to carve out space for free speech within FDA guidelines.
"This decision has tried not to touch the FDA regulatory regime," Gibson said. "It may prompt the FDA to issue more guidance on a number of topics."
One key area would be guidance on what sales reps can say when doctors initiate discussions of off-label use of drugs.
"What this decision says is that if a sales person is truthful with the doctor, they can't be prosecuted," Gibson said.
Pharmaceutical reps and companies have been prohibited from marketing drugs for uses other than those shown safe and effective in clinical trials and approved by the FDA. Doctors could prescribe the drugs and patients could take them, but companies could not promote those drugs for those uses.
Pharmaceutical companies and their business backers are eager for more freedom. But the fear of regulators - and Circuit Judge Debra Ann Livingston, who wrote the dissent in the 2-1 decision - is that the remaining constraints that speech must be truthful and not misleading will be lost in the waves of promotion.
Gibson said she is still advising clients to be a careful.
"Our advice to life sciences companies is not that much different than it was before Caronia, which is that the NDA rules apply and that promotional activities including speech must be supported by studies that show safety and efficacy of the product for the intended use, as reflected in the label," Gibson said. "The decision does nothing to prevent the government from prosecuting for misleading speech, misbranding or some kind of omission of important information about safety or efficacy in connection with off-label use of a product."
Because there are limits to the First Amendment.
"Yes," Gibson said. "The First Amendment protects truthful speech and truthful promotion."

 

How Caronia Could Reshape Government Investigations
Law360, New York (January 02, 2013, 12:32 PM ET) --

John Bentivoglio
Truthful, nonmisleading speech promoting the lawful off-label use of an approved drug or device is constitutionally protected.
This belief, long articulated by free speech advocates, many within U.S. Food and Drug Administration-regulated industries, and by physicians, is now the law in the U.S. Court of Appeals for the Second Circuit, which vacated Alfred Caronia's conviction after concluding that it had been based on speech protected by the First Amendment. The court's decision in United States v. Caronia is likely to have myriad consequences, and could reshape the federal government's enforcement efforts, the manner in which physicians and consumers receive information, and the business practices of FDA-regulated industry.
While the full effect of the Caronia decision will play out over time, the central holding in Caronia, that the First Amendment protects truthful, off-label information, may remain contentious as federal prosecutors try to preserve what has been a powerful and profitable enforcement theory facing additional legal challenges.[1]
The basic facts giving rise to the Caronia decision are relatively well known. Alfred Caronia was a sales representative for Orphan Medical (later acquired by Jazz Pharmaceuticals), which manufactured and promoted Xyrem. Xyrem was a schedule II controlled substance, and, during the time period in question, was approved only for cataplexy associated with narcolepsy. The U.S. Department of Justice prosecuted Caronia for promoting Xyrem for nonapproved uses.[2] Caronia was eventually charged with two misdemeanor counts: conspiring to misbrand Xyrem, and misbranding Xyrem. A jury found Caronia guilty of conspiring to misbrand Xyrem, and acquitted him of the underlying misbranding charge. He received a $25 fine, one year of probation and 100 hours of community service.
In vacating Caronia’s conviction, the Second Circuit focused on the government’s theory of liability, as demonstrated by its evidence and arguments at trial. While recognizing that off-label promotion “plainly” had occurred, the court rejected “as simply not true” the government’s argument that it had not prosecuted Caronia for his speech, but rather that it had merely used the speech as evidence that the off-label uses were intended uses for which the drug’s labeling provided no directions. In rejecting the government’s post-hoc theory of prosecution, the court stated, “[e]ven assuming the government can offer evidence of a defendant’s off-label promotion to prove a drug’s intended use and, thus, mislabeling for that intended use, that is not what happened in this case.”
The court concluded that the government’s contention “was belied by its conduct and arguments at trial,” noting that the government highlighted Caronia’s “off-label promotion of Xyrem … over forty times” in its closing argument and rebuttal at trial. The court found that “the government clearly prosecuted Caronia for his words — for his speech. A pharmaceutical representative’s promotion of an FDA-approved drug’s off-label use is speech.”
After recognizing that “Caronia plainly promoted the use of Xyrem in unapproved indications” and concluding that the government had premised its prosecution solely on Caronia’s speech relating to these unapproved uses, the court went on to evaluate whether the government’s construction of the Food, Drug and Cosmetic Act’s misbranding provisions as criminalizing a pharmaceutical manufacturer’s truthful, nonmisleading speech about a drug’s off-label use violated the First Amendment.
The court relied on the First Amendment analysis articulated by the U.S. Supreme Court in Sorrell, which was decided after Caronia’s trial, in observing that “[c]riminal regulatory schemes, moreover, warrant even more careful scrutiny.” The court held that the government’s interpretation of the misbranding provisions are content-based and speaker-based and are therefore subject to heightened scrutiny.
Like the Supreme Court in Sorrell, the Second Circuit declined to identify the level of heightened scrutiny it employed. Next the court turned to the Central Hudson four-part test to determine whether commercial speech is protected by the First Amendment. The court found that the government’s speech restrictions were not supportable under the third and fourth parts of the Central Hudson — namely, that the restriction “must advance the governmental interest asserted … to a material degree” and that the restriction must be “narrowly drawn.”
The court further noted that the “government’s construction of the FDCA essentially legalizes the outcome — off-label use — but prohibits the free flow of information that would inform that outcome.” “We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful off-label use of an FDA-approved drug.”
The court found that “such a construction — and a conviction obtained under the government’s application of the FDCA — would run afoul of the First Amendment.” The court declined to address the broader question of whether off-label promotion is tantamount to illegal misbranding, noting that it was construing “the FDCA narrowly to avoid a serious constitutional question.”
The language of the Second Circuit decision is important to understanding the scope of the opinion. While the appeal involved an individual who had been prosecuted for criminal violations of the FDCA, the decision spoke to both individuals and manufacturers: “We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful off-label use of an FDA-approved drug.” This broad language, applicable to companies and their employees, should apply equally to truthful speech about the off-label uses of medical devices.
The most immediate impact will likely be in ongoing government investigations. In matters where there has been little or no evidence that the manufacturer or its representatives made false or misleading statements, the government will likely redouble its efforts to locate admissible evidence of false or misleading speech. Without this type of evidence to support a misbranding charge, the government's primary theory of criminal liability, has been removed, and the cases should be closed.
The court's holding that only false or misleading promotion is violative should have the effect of mitigating settlement amounts, since damages would be limited to the subset of off-label sales that are based on alleged false or misleading speech. Finally, the decision should also have a limiting effect on False Claims Act investigations premised on off-label promotional activities. If the purported off-label promotion is not false or misleading, it is difficult to see how a claim resulting from such speech could be “false” under the FCA.
The Caronia decision is a watershed event in many ways. The government's theory of off-label liability deployed for so long and so prominently as part of settlements rather than in litigation, now has been rejected by an appellate court. Going forward, investigations likely will focus on the distinction between truthful, nonmisleading information and that which is false or misleading. This will form the new battleground between prosecutors and those under investigation. An important component to the government's evaluation will be ensuring that personnel from FDA are involved in evaluating the facts at the preliminary stages so that the associated medical and scientific questions can be examined.
Questions will arise such as: How much disclosure is needed for a truthful statement not to be misleading? Will a truthful statement about a clinical trial, in the course of a brief hallway conversation, be misleading if the conversation does not include a contrary study? At a minimum, the decision should cause federal prosecutors and regulators to pause and consider the public health interest that is served by ensuring the flow of accurate information between manufacturers and the physicians who prescribe drugs and devices for their patients.
In the final analysis, the goal of the Food Drug and Cosmetic Act is designed to protect the public health by ensuring that Americans have access to drugs and medical devices that are safe and effective. Almost all drugs and devices have off-label uses and it is a cornerstone of our health care delivery system that physicians may choose to use products for off-label uses when treating their patients. The Second Circuit's message is that, if the information is truthful and not misleading, the Constitution guarantees the right of anyone, including a sales representative, to deliver that message.

--By John T. Bentivoglio, Jennifer L. Bragg, Michael K. Loucks and Gregory M. Luce, Skadden Arps Slate Meagher & Flom LLP
John Bentivoglio and Jennifer Bragg are partners in Skadden's Washington, D.C., office. Michael Loucks is a partner in the firm's Boston office. Gregory Luce is a partner in the firm's Washington office.

 

The New Yorker

May 21, 2014

A New Kind of Free Speech: Drug Reps’ Pitches to Doctors

by Kiel Brennan-Marquez

Can a pharmaceuticals representative tell a doctor that he should recommend Bupropion, an anti-depression drug, to help patients quit smoking? What about suggesting Zoloft to help with certain sex problems? Currently, the answer is no: when the Food and Drug Administration approves a drug, it specifies which uses may appear on the label, and it bars pharmaceuticals companies from promoting “off-label” uses to doctors. (Doctors themselves, however, may prescribe drugs for off-label purposes.) But pharmaceuticals companies and their lobbyists have raised concerns that this ban could violate the First Amendment. And at the recent annual meeting of the Food and Drug Law Institute, in Washington, D.C., Leslie Kux, the assistant commissioner for policy at the F.D.A., suggested that the agency is reconsidering its rules.

You might be wondering what these labelling policies have to do with freedom of speech. Well, if you construe drug reps’ conversations with doctors as speech, then F.D.A. rules that restrict those conversations arouse First Amendment concerns. They limit what kind of “commercial speech”—the Supreme Court’s term for advertising and other messaging undertaken by for-profit companies—is allowed.

For most of the history of the United States, the Supreme Court understood advertising and promotion to fall outside the bounds of the First Amendment: no matter how much a law restricted commercial speech, it couldn’t be challenged. Then, in 1976, the Court struck down a Virginia law that prohibited pharmacists from advertising the prices of the drugs they sold. The Justices reasoned that “the suppression of prescription drug price information,” whatever its upside, came at the expense of vulnerable consumers: “the poor, the sick, and particularly the aged.” In other words, the Virginia law restricted listeners’ access to speech (in the form of price information) that the First Amendment entitled them to.

From these auspicious beginnings, the idea of commercial speech has transformed into a tool for big companies to fight regulation. In 2011, the Supreme Court struck down a Vermont statute that prohibited pharmaceuticals companies from getting access to information about the prescriptions doctors were writing—information that the companies then used for marketing purposes. The Vermont legislature saw the law as a run-of-the-mill privacy protection. But to six Supreme Court Justices the Vermont law amounted to an unconstitutional restriction on speech: by restricting the information that pharmaceuticals sales reps could gather, it limited what they could say while marketing the drugs. The case—IMS Health v. Sorrell—exemplified a newfound willingness among federal judges to view drug promotion as an issue of free speech. Now when large companies lose advertising-related battles in the legislature, they can resurrect the fights as lawsuits.
In 2012, the U.S. Court of Appeals for the Second Circuit considered the case of a pharmaceuticals sales rep, Alfred Caronia, who had been charged with “misbranding” Xyrem, a drug approved to treat some types of narcolepsy. At trial, Caronia had been found guilty of promoting Xyrem’s off-label uses to physicians—for example, recommending the drug to treat other sleep disorders—and had been sentenced to a year of probation and community service. The Second Circuit, relying on the Sorrell decision, determined that punishing Caronia for “promoting the lawful, off-label use of an F.D.A.-approved drug” was a violation of the First Amendment.

At the time of the Caronia decision, Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group that represents big biopharmaceuticals companies, had been mounting First Amendment arguments against restrictions on off-label promotion for at least a decade. In a 2002 filing with the F.D.A., PhRMA argued that F.D.A. rules concerning the dissemination of “truthful, non-misleading speech about lawful products and activities”—like the off-label prescription of drugs—should be “scrutinized” through the “First Amendment lens.” The organization has been “consistently noting” these problems for the past twelve years, according to Stephanie Fischer, a spokeswoman. But the recent Sorrell and Caronia decisions could give their arguments more traction.
On March 3rd of this year, the F.D.A. solicited public input about whether, and to what extent, drug reps should be allowed to inform doctors about scientific research regarding off-label uses of drugs. In a response to the draft guidance, PhRMA urged the F.D.A. to make its regulations “conform with the First Amendment” so as to “ensure that healthcare professionals may benefit from scientifically accurate, data-driven information.” The message was clear: stop limiting the flow of information to physicians.

PhRMA argues that doctors already prescribe drugs for off-label uses and don’t rely only on pharmaceutical labels to decide the best course of medical action. Mit Spears, the general counsel of PhRMA, argues that the right regulatory approach would be one that enables pharmaceutical sales reps to get drug studies, prescriber data, and other medically relevant information into the hands of doctors, to inform decisions about off-label uses.
Other experts take a more skeptical view of off-label promotion. Amy Kapczynski, a professor of intellectual property and public health at Yale Law School, where I am a fellow, would caution the champions of off-label use to remember that there’s a reason these uses aren’t on the label: they haven’t been shown to be safe. Because privately underwritten studies rarely replicate the stringency of the research used in the F.D.A. approval process, off-label uses are simply not as reliable as their “on-label” counterparts. As Kapczynski put it, “Without testing, and rigorous and independent review of the results, we simply have no way of knowing how new populations will respond to repurposed drugs.” She offered the example of Gabitril, a drug approved to help treat epileptics. When Gabitril was promoted off-label to non-epileptics—for things like anxiety—the drug turned out to cause seizures.
Another organization that responded to the F.D.A.’s March 3rd solicitation for public input was the American Medical Association, which came out in favor of letting sales reps incorporate scientific studies about off-label uses into their promotional materials but also emphasized that the information should be “accurate and unbiased.” In the abstract, this seems like a sensible compromise. But it’s not an easy balance to strike. As doctors continue to prescribe drugs for off-label uses, they need information about how those uses stand to affect patients. Yet the parties with the most information—pharmaceuticals sales reps—inherently have financial incentives to promote off-label uses. There’s good reason to be concerned about the distortion that can result from privately financed scientific research; after all, it’s one of the reasons we require F.D.A. approval of drugs in the first place.


Read more: http://www.newyorker.com/online/blog...#ixzz32O7Ikul4

 

Congratulations to Al. You have endured the wrath of the intrusion of the government into the affairs of medical providers in their feeble attempt to keep the jails filled and the money rolling in. You are a hero in my book. Sadly the prosecutor was not bound to tell the truth and he lied and he lied and he lied.

Way to go brother!

 

expensive fantasy only in reality one man will endure this for life and two are dead

 

Way to go Al. I hope you can find a place to put the years of abuse you were forced to endure to prove your innocence. I remember working with you and want you to know we had your back - problem was there was and still is a knife jabbing us in the ribs.

 

Hey congrats Al.

 

From an Investors point of view it is really scary to see "Latoya & Jermaine" policing every little post on this page. Latoya posts as if she is the director sales / board of the cartel "The Family" and they are working on snuffing out those on the street not "EARNING" properly.

Those "misfits" "incompetent" and the other really personal hate terms she uses... Those that need help, pointing out that an actual employee was terminated for being somewhat crazy and that the company suggested "getting help". This should all be very private information or at the very least never posted "Anonymously" or not !

What kind of company allows a Director, of all people to battle with what they consider a known "headcase" on a public forum ?

LaToya... Does the upper management know that you are policing with so many responses, quibbling like a 25 year old protecting their child after a school yard fight ?

Please try to remember that some really BIG money investors may be reading what you write. We have the money, it would not be hard for us to find out who you are. Especially if you are writing all of this without Heathers approval...