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Human Rights Defenders

“All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.”

 Universal Declaration of Human Rights

Article 1

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Pharmaceutical Representative

Off-Label Promotion

Off-label promotion—pharmaceutical manufacturers’ marketing of FDA-approved drugs for unapproved uses—is considered by many to be a threat to public safety. The Federal Food, Drug, and Cosmetic Act (FDCA) and corresponding FDA regulations effectively prohibit off-label promotion. The Food and Drug Administration has a strong interest in protecting the public health through the approval process for new drugs, and thus the right to place restrictions on off-label promotion. The very purpose of the Federal Food, Drug, and Cosmetic Act (FDCA), which seeks to protect the public by ensuring that pharmaceutical drugs are safe and effective for their intended uses. 21 U.S.C. § 393(b) (2012). The truth about the risks and benefits of off-label uses, is often based on manufacturer financed research, unverified research not reviewed by the FDA regulatory experts. Pharmaceutical industry researchers are paid to keep quiet about research findings that indicate potential concerns. Not only do companies spend substantially more money on marketing than on research, but a substantial proportion of the marketing budget is allocated to detailing. Detailing, is the practice of sales representatives visiting doctors in their offices to promote drugs. This is extremely effective in influencing doctor's prescription choices and is used as a means of off-label promotion. Off-label prescription is common, with perhaps more than twenty percent of prescriptions written for off-label uses.

Off Label Promotion GlaxoSmithKline

Henry Waxman -Promotion of Prescription Drugs

FDA enforcement of provisions barring false and misleading advertisements has over the years continued to decline.  FDA’s responses to false and misleading advertisements were not timely, and delays increased.  The few actions taken by FDA have little deterrent effect.

http://oversight-archive.waxman.house.gov/documents/20040818103834-43053.pdf

Date Rape Drugs

Xyprem is the sodium salt of GHB

Xyrem - Sodium oxybate is GHB the commonly used date rape drug. GHB or Gamma Hydroxybutyrate (C4H8O3) is a central nervous system (CNS) depressant that is commonly referred to as a “club drug” or “date rape” drug. Xyrem (sodium oxybate), a brand name prescription drug was approved by the Food and Drug Administration (FDA) in 2002 for the treatment of narcolepsy, a sleep disorder that causes excessive sleepiness and recurring daytime sleep attacks. It is the sodium salt of gamma hydroxybutyrate (GHB). Xyrem is a highly regulated drug in the U.S. It is a Schedule III controlled substance, and requires patient enrollment in a restricted access program. In 1990, the Food and Drug Administration (FDA) issued an advisory declaring GHB use unsafe and illegal except under FDA-approved, physician-supervised protocols. In March 2000, GHB was placed in Schedule I of the Controlled Substances Act. The sodium salt of GHB, the brand product Xyrem (sodium oxybate), is a Schedule III drug when prescribed and used legally in a patient restricted-access program. Xyrem is not available at regular retail pharmacies. Xyrem and illegal GHB metabolize within the body and have the same actions on mental abilities and systemically within the body. If Xyrem is trafficked as a recreational drug, it’s status converts to Schedule I and it becomes an illegal drug.

Ex-Pharmaceutical Representative

DEA Drug Fact Sheet GHB

http://www.justice.gov/dea/druginfo/drug_data_sheets/GHB.pdf

GAO Prescription Drugs Off Label Promotion

GAO Report: Prescription Drugs:Implications of Drug Labeling and Off-Label Use

T-HEHS-96-212: Published: Sep 12, 1996. Publicly Released: Sep 12, 1996.

http://www.gao.gov/assets/110/106648.pdf

FDA Drug Approval Process

Research and development of a new drug and the attainment of FDA approval is very expensive.  The process of testing a promising new drug and then securing approval of a new drug application (NDA) requires a substantial investment of time and resources, averaging on the order of a dozen years and over $1 billion.

The FDA has many restrictions on off-label promotion which help convince  pharmaceutical companies to seek FDA approval. There is a legal difference between permitted marketing of on-label as opposed to "off-label uses”  and these restriction need to be  adequate to safeguard the both FDA approval process and the public health.

When the brand-name manufacturer gets agency approval for a new use, it generally secures three additional years of market exclusivity on just that use.  Generic drug manufacturers profit from the brand name drugs' research and development when that 3 year period is up.  Then the Generics can market the same drug as a generic at dramatically lower prices and as a  generic substitution.

Essentially although pharmaceutical companies target doctors for off-label promotion, the real  risks and consequences associated with unapproved drugs are passed on to patients who are frequently unaware of a drug’s unapproved status and receive no information with which to assess the risks and benefits of a disclaimer.

If the drug goes to market and then is later found to have problems, postmarket enforcement takes months or even years, during which time a drug remains on the market, exposing patients to dangerous or ineffective treatment.

Off-Label Promotion

United States v Caronia

 

United States v. Caronia involved the conviction of Alfred Caronia, who was a former sales representative for Orphan Medical, U.S. v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012).   This was a criminal prosecution of Mr. Caronia for criminally violating FDA statues in the off-label promotion of this very dangerous, very controlled drug Xyrem.  Xyrem was given extremely limited rights to market their drug under very tight clinical control.  But the company was violating the FDA rules and promoting the drug for off-label use - use that was not considered by the Food and Drug Administration to be safe or effective


Mr. Caronia was selling Xyrem, and promoting the drug extra-label for unapproved uses.  Mr. Caronia recently appealed the conviction in the United States court system, arguing that his right to free speech under the First Amendment was being illegally restricted. It is likely that this case may be further appealed to US Supreme Court. The Federal Court in New York, the Second Circuit’s Caronia decision if it stands could drastically change how the Food and Drug Administration (FDA) and Department of Justice (DOJ) enforce the 21 U.S. Code Chapter 9 – Federal Food, Drug, and Cosmetic Act's (FDCA’s) Sub-chapter V mis-branding provisions and thereby significantly increase the extra-label or off-label use of this drug and many other prescription drugs.  Criminal "off-label" promotion of this dangerous drug and deliberate with holding of direct evidence from the US Food and Drug Administration of adverse events and even deaths of persons in the clinical trials, will
directly impact how this drug is promoted and marketed in the UK and Europe.

Making a Killing

Involuntary Committment

Human Rights - Patient's Right to Informed Consent

There is an international human rights issue involved in this US vs Caronia case – that of human subjects experimentation as delineated in the Nuremberg Code. In the United States of America, the Common Rule regulates human subject use by pharmaceutical researchers and yet none of these precautions are in place for patients being given off-label or extra-label prescription drugs. Patients who are receiving extra-label drugs do not know the full risks of those medications and are instead unwitting human subjects in a clinical research trial that has no human rights protections and no monitoring or surveillance by governmental regulators. Clinical doctors are deceived by a clever marketing scheme. The pharmaceutical companies are promoting drugs extra-label in order to use regular patients as human subjects so as to get a large human subject base to expand the commercial marketing of their product without governmental regulation and control.

Dollars for Doctors

Xyrem - Patient Deaths

According to the report by Quarterwatch™ Report (Quarters 2 and 3, 2013) Sodium oxybate (Xyrem): High adverse event report rate19% of adverse events were related to off-label use.www.ismp.org/QuarterWatch/.

Xyrem is a powerful central nervous system (CNS) depressant. The drug can cause serious side effects including difficulty breathing while asleep, confusion, abnormal thinking, depression, nausea, vomiting, dizziness, headache, bedwetting, and sleepwalking. If abused, Xyrem can cause seizures, dependence, severe withdrawal, coma, and even death. The active ingredient in Xyrem is gamma-hydroxybutyrate (GHB), which is also called the “date rape drug” because of its association with sexual assaults. …. Jazz Pharmaceuticals, the manufacturer, published an optimistic safety overview of sodium oxybate in 2009 in a medical journal and gave a similar portrayal at a 2010 FDA meeting. However, in 2011, Jazz revealed that it had included only 21 of 103 reported patient deaths. The problem was traced to inadequate coordination of reporting procedures with the central pharmacy that distributed the prescriptions. Quarterwatchidentified an unexpectedly high number of serious ADEs reported for the drug given its use by a small patient population of approximately 9,000 in 2013. Sodium oxybate accounted for more reported serious ADEs than other drugs taken by millions of patients. According to the reports, the drug was suspect as causing adverse effects on motor control (e.g., falls, bedwetting), the extrapyramidal motor system (e.g., dystonia, Parkinsonism, akathisia), memory and alertness (e.g., blackout, memory loss), and mood and behavior (e.g., depression, psychosis, hostility, suicidal behaviors). Serious reported ADEs involved 15% of the exposed population, measured in patient years. Close follow-up with patients and manifestations of the disease itself could account for the high total of reported events. There are also safety concerns associated with the off-label use of sodium oxybate, which was illegally promoted by Jazz’s predecessor company for use in insomnia and various psychiatric disorders. Quaterwatch found that off-label use was documented in at least 19% of the reported ADEs, including fibromyalgia, insomnia, and unspecified sleep disorders. Given the risks now seen in the current adverse event reports, questions remain whether the drug’s benefits justify its unusually high risks, and whether off-label use has been or could be controlled.”

Former RX Drug Pusher

Xyrem & Criminal Exploitation

Those wishing to profit from widespread distribution of Xyrem have launched a huge promotional campaign which aims to portray Xyrem-GHB as a safe prescription drug and to portray all Xyrem-GHB rape victims as voluntary illegal substance abusers.  This shames and  blames victims sexually assaulted or sexually exploited by the use of this drug, who fear for their reputations when coming forward to testify.  The insistence of the pharmaceutical industry that these drug facilitated sexual assault victims/survivors are all actually illegal drug addicts misses the point that many initially had the drug slipped to them surreptitiously or even were force addicted to it by their human trafficking captors.  It also does not address the fact that this drug is easily used for other kinds of crime, including interrogation, forcing confessions, extortion, blackmail, fraud, forgery, and organized crime activities. No one is asking the question - are the patients in the clinical trials and off label use of Xyrem being sexually exploited. Would patients even report it, considering that this drug erases memory for the period of time it is in the system. The company wishing to expand the clinical extra-label use of this drug is not gathering sexual exploitation and sexual assault information.  

How will we deter the use of GHB to facilitate human trafficking if ready dosages of extra-label or off-label Xyrem are available legally to perpetrators. I respectfully ask how can we adequately control this drug if it gains widespread distribution because of unregulated extra-label clinical use ?

GHB in Belgium

Coroners & ME's Don't Detect GHB

In the U.S.A. the National Forensic Laboratory Information System data indicated that GHB rarely is identified in drug items analyzed by state and local forensic laboratories. Dr. Deborah L. Zvosec, Ph.D., Research Associate, Department of Emergency Medicine Hennepin County Medical Center, Minneapolis, MN did research to identify 226 deaths from GHB & analogs that occurred from 1995-2005. The 226 deaths that she identified included 155 men and 71 women, including 209 in the U.S. (36 states), 4 in Canada (Quebec), and 13 in the UK. Ages ranged from 15-53 years (average: 28 years). Of the 226, 207 deaths were classified as GHB-caused, in which toxic effects of GHB caused or contributed to death. GHB is lethal with and withoutother drugs or alcohol. GHB/analogs are notsleep-it-off” drugs. She notes that:

  1. routine toxicology tests used by hospitals and ME’s do not detect GHB/analogs;

  2. many coroners and ME’s are unfamiliar with GHB/analogs and do not know to request specific tests to detect them;

  3. limited funds are available for death investigations, so toxicology testing often stops when other drugs are detected;

  4. there are no centralized databases to indicate when and where GHB-associated deaths are detected;

  5. death records are often un-searchable, due to limited technology and/or funds; and

  6. access to death records is, in some states, limited by privacy concerns.

Truth about Drug Marketing

Xprem vs Patient's Right to Informed Consent

The development of necessary model protocols and training materials to help educate and protect the public were placed into Section 7(b)(3) of the Hillary J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000 (Public Law 106–172; 21 U.S.C. 801 note). But the funding was cut due to pressure by the pharmaceutical industry. All the while, Orphan Medical, and now, Jazz pharmaceutical Inc. were aggressively pursuing legal means to expand the extra-label use of Xyrem-GHB while simultaneously withholding adverse event and Xyrem-GHB deaths information from the FDA and prescribing clinicians. This off-label promotion of Xyrem-GHB is not constitutionally protected free speech – commercial or otherwise, it is deceptive marketing of a very dangerous drug, and prevention of the public's right to know the risks of taking prescription medication. Jazz Pharmaceutical withholding information from the FDA about Xyrem deaths and reporting only 21 of 103 reported patient deathsis a direct interference in the ability of the US government – the Food and Drug Administration to adequately regulate this drugs' use. Political pressure applied by the pharmaceutical company on Congress which eliminated funding for the development of necessary model protocols and training materials to help educate and protect the public, means that 15 years after Samantha Reid's death many law enforcement personnel, toxicologists, medical examiners and coroners are still not adequately trained to use proper protocols in Xyrem-GHB deaths. This compromises the ability of the Drug Enforcement Agency (DEA) to adequately enforce the criminal statutes related to Xyrem-GHB. In addition training about the dangers of Xyrem-GHB also was not done within the medical community or for doctors, therapists, psychologists and rape counselors. Victims/survivors of Xyrem-GHB related crimes – sexual assault, prostitution, human trafficking are therefore not getting the needed services they need nor the criminal prosecution of the perpetrators that they deserve.

Big Pharma Manipulating Doctors

FDA Regulation

Under the FDCA, each new drug must undergo a rigorous approval process to show that it does what it purports to do and that, with respect to its intended uses, the benefits of the drug outweigh the risks. Id. § 355. The U.S. Food and Drug Administration (FDA) is charged with overseeing the approval process for new drugs. Part of that process includes reviewing all of the manufacturer’s clinical studies, both positive and negative, and approving a label that includes the indications, dosage, precautions, warnings, and contraindications. 21 C.F.R. § 314.50 (2013). The FDA ensures that the labeling is not “false or misleading in any particular.” 21 U.S.C. § 355(d). Introducing a drug into interstate commerce without proper labeling constitutes the crime of “misbranding.” Id. §§ 331(a), 352(a).

Medicaid Pays For Fraud

Supreme Court - Commercial Speech

The Supreme Court has held

that the government is “free to 

prevent the dissemination of commercial speech that is false, deceptive, or misleading, or that proposes an illegal transaction.”

Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 638 (1985)

The Supreme Court identified the threshold inquiry in commercial speech cases as whether the speech is misleading: misleading speech, the Court stated, “is not protected by the First Amendment.”

Western States, 535 U.S. at 367.

But the intent of Caronia's commercial speech was to mis-brand the product and to insinuate to doctors through detailing and off-label marketing that Xyrem is a safe prescription drug, when Jazz Pharmaceuticals already knew that the pharmacy dispensing the clinical trial drug was under-reporting all adverse events and even not reporting many of the known deaths on the product. Jazz pharmaceuticals only reported to the FDA 21 of 103 deaths - out of a patient base of only 9,000 people.

Therefore we believe that Caronia’s speech could be taken as evidence of his intent to introduce a mis-branded drug into interstate commerce.  This was not truthful off-label speech but instead an intent to deceive doctors with falsely inflated claims of efficacy and with held statistics of serious adverse events. 

In Wisconsin v. Mitchell, the Supreme Court held that the First Amendment “does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent.” 508 U.S. 476, 489 (1993). 

 

Political Psychiatry

Henry Waxman on High Prices for Seniors

Prescription drug manufacturers charge senior citizens the highest prices in the world for prescription drugs. Study after study reveals the broad extent of drug companies' price discrimination.  Not only do uninsured seniors pay double what favored U.S. customers pay, our studies show that they also pay twice what consumers in Mexico and Canada are charged for the same drugs. We even discovered that when drugs are used to treat animals as well as people, manufacturers price the human version far higher than what they charge for the animal version --for the same medicine. Older Americans who use prescription medications -- nearly 90% of seniors-require an average of over 20 drug prescriptions a year.  And this year, almost one quarter of seniors will spend $2000 on drugs alone.

http://waxman.house.gov/sites/waxman.house.gov/files/documents/OpEd%20on%20Prescription%20Drugs.pdf

Pharma Not in Business of Health

Globalization of Pharmaceutical Products

With the increasing globalization of commerce and trade, and the merging of pharmaceutical companies, there is a clear impact of pharmaceutical production and regulatory changes in one country affecting availability of drugs in another. International norms and standards for prescription medications are thus more important than ever before. WHO helps to develop such international norms and standards, and assists countries implementing them.  The pharmaceutical industry in the USA has now flooded our marketplace with a range of drugs which have never been proven to be safe or effective in clinical trials by the Food and Drug Administration. The Food and Drug Administration has allowed off-label prescription drugs to be prescribed by doctors at their will and has only cracked down on off-label marketing and promotion efforts of the pharmaceutical companies. But now the companies are claiming as corporations they have the right to Constitutional Corporate free speech and thus can promote drugs that are not approved by FDA for any use at all, even for a diagnosis for which they are not safe or effective. It is important to the health of the public that high standards of quality, safety, and efficacy of medicines must be ensured and reliable systems of medicines regulation and legislation be enforced here in the USA. US lack of regulation and control affects the pharmaceutical products available in other countries and directly impacts their own regulatory agencies.

History of FDA Off-Label Information

P T. Aug 2009; 34(8): 428–440.
PMCID: PMC2799128

Off-Label Drug Information

Regulation, Distribution, Evaluation, and Related Controversies
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2799128/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2799128/pdf/ptj34_8p428.pdf

References

  1. Zvosec D, Dyer J, Porrata T, Smith S, Strobl A. Preventable deaths associated with Gamma
    hydroxybutyrate (GHB) ingestion: 226 fatalities (Abstract 49). European Journal of Emergency
    Medicine 2008;15:304.

  2. Zvosec D, Smith S, Porrata T, Strobl A, Dyer J. Fatal motor vehicle collisions while Gamma hydroxybutyrate (GHB)-intoxicated. Proceedings of the Joint Annual Meeting of the International Council on Alcohol, Drugs, and Traffic Safety (ICADTS) and the International Association of Forensic Toxicologists (TIAFT), Seattle, WA, August 29, 2007.

  3. Zvosec DL, Smith SW, Porrata T, Strobl AQ, Dyer J. Preventable deaths from Gamma hydroxybutyrate ingestion. Abstract 247. Annals of Emergency Medicine 2006;48(4):S75.

  4. Zvosec DL, Smith SW, Porrata T, Quinn AQ, Dyer JE. 226 Gamma hydroxybutyrate (GHB)-associated fatalities: Overlap of postmortem GHB levels with endogenous, therapeutic, and non-fatal GHB toxicity cases and factors supporting exogenous origin. Oral presentation at the Annual Meeting of the National Association of Medical Examiners, Savannah GA, October 13, 2007.

  5. Federal Register 65; 13235-13238, 2000.

  6. DEA Fact Sheet: Gamma Hydroxybutyric Acid (GHB, liquid X, Goop, Georgia Home Boy)   http://www.justice.gov/dea/pubs/pressrel/pr031300_01.htm

  7. National Drug Intelligence Center, US Department of Justice Bulletin, September 2004 Product No. 004-L0424-015 “GHB Trafficking and Abuse”,       http://www.justice.gov/archive/ndic/pubs10/10331/10331p.pdf

  8. “21 USC, Section 801.” Office of Diversion Control . N.p., n.d. Web. 26 June 2013. http://www.deadiversion.usdoj.gov/21cfr/21usc/801.htm.

  9. “Date Rape Drugs.” womenshealth.gov. Ed. Susan Weiss. N.p., n.d. Web. 26 June 2013. http://www.womenshealth.gov/publications/our-publications/fact-sheet/date-rape-drugs.html.

  10. David C. Radley et al., Off-Label Prescribing Among Office-Based Physicians, 166 Archives Internal Med. 1021, 1023 (2006).

  11. Puneet Manchanda & Elisabeth Honka, The Effects and Role of Direct-to-Physician Marketing in the Pharmaceutical Industry: An Integrative Review, 2 Yale J. Health Pol’y L. & Ethics 785, 785-86 (2005). Evidence shows that doctors are susceptible to these marketing techniques and that their prescribing habits are impacted.

  12. Adriane Fugh-Berman & Shahram Ahari, Following the Script: How Drug Reps Make Friends and Influence Doctors, 4 Plos Med. 621, 623-24 (2007).

  13. Erika Kelton, Off-Label Pharma Prosecutions Won’t Be Silenced by First Amendment Decision, Forbes (Jan. 4, 2013), http://www.forbes.com/sites/erikakelton/2013/01/04/off-label-pharma- prosecutions-wont-be-silenced-by-first-amendment-decision.

  14. FDA, Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices 2-3 (2009), available at http://www.fda.gov/ oc/op/goodreprint.html.

  15. Michelle M. Mello et al., Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals, 360 New Eng. J. Med. 1557, 1558 (2009), available at http://www.hsph.harvard.edu/ michelle-mello/files/2012/10/Off-label_PDF.pdf.

  16. Christopher Robertson, When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment, 94 B.U. L. Rev. (forthcoming 2014) (manuscript at 127-31), available at http://papers.ssrn.com/id=2318618.

  17. Lars Noah, Death of a Salesman: To What Extent Can the FDA Regulate the Promotional Statements of Pharmaceutical Sales Representatives?, 47 Food & Drug L.J. 309, 312-15, 323-26 (1992).

  18. For Consumers: Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review: Expediting Availability of New Drugs for Patients with Serious Conditions, FDA (June 26, 2013), http://www.fda.gov/ForConsumersByAudience/
    ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm.

  19. Jim Edwards, Lesson From Pfizer: Don’t Describe Your Product as “Snake Oil” in Internal Email, CBS MoneyWatch (Mar. 26, 2010), http://www.cbsnews.com/news/lesson-from-pfizer-dont-describe-your-product-as-snake-oil-in-internal-email.

  20. P.A. Francis, Pfizer Inc. Guilty, PharmaBiz (May 19, 2004), http://saffron.pharmabiz.com/article/detnews.asp?articleid=21919§ionid=47&z=y

  21. Pfizer Pays $2.3 Billion to Settle Marketing Case, N.Y. Times (Sept. 3, 2009), http://www. nytimes.com/2009/09/03/business/03health.html.

  22. Donald W. Light et al., Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs, 41 J.L. Med. & Ethics 590, 595 (2013).

  23. Malcolm S. Salter, Lawful but Corrupt: Gaming and the Problem of Institutional Corruption in the Private Sector (Harvard Bus. Sch., Working Paper No. 11-060, 2010) (manuscript at 14-25), available at http://www.hbs.edu/faculty/Publication
    %20Files/11-060.pdf.

  24. Marc A. Rodwin, Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use, 41 J.L. Med. & Ethics 654, 659-60 (2013).

  25. Aaron S. Kesselheim et al., Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints, PLoS Med., Apr. 2011, at 7

  26. Henry A. Waxman, A History of Adverse Drug Experiences: Congress Had Ample Evidence to Support Restrictions on the Promotion of Prescription Drugs, 58 Food & Drug L.J. 299, 301-02 (2003)

Marking Madness

Prescription Drugs FDA's Oversight

GAO report number GAO-08-835 
entitled 'Prescription Drugs: FDA's Oversight of the Promotion of Drugs 
for Off-Label Uses' which was released on July 29, 2008.

Summary 
http://www.gao.gov/assets/280/278841.pdf

Full Report 
http://www.gao.gov/assets/280/278832.pdf

Highlights 
http://www.gao.gov/products/GAO-08-835

http://www.gao.gov/assets/280/278836.html

 

GAO criticizes FDA oversight of off-label promotion

Pharma Compliance Alert, July 30, 2008

The FDA takes too long to warn a pharmaceutical company about off-label promotion, according to a Government Accountability Office (GAO) report.

According to the GAO, the FDA:
  • Takes an average of seven months to warn a company about possible violations
  • Is unable to review all submissions because of the volume of materials it receives
  • Prioritizes reviews to examine those with the greatest potential impact on human health
  • Relies on staff to sort though large volumes of material and prioritize them for review
  • Is hampered by the lack of a system that consistently tracks the receipt and review of submitted materials

Between 2003 and 2007, the FDA issued 42 letters requesting companies stop marketing products for off-label uses, but did not refer any of the violations to the Department of Justice (DOJ) for enforcement actions. During the same time, the DOJ settled 11 civil and criminal cases that involved off-label marketing to some extent.

Senator Charles Grassley (R-IA) requested the review.

 

FDA Advisory Committees

GAO 1996 Report on Prescription Drugs

Prescription Drugs:

Implications of Drug Labeling and Off-Label Use

T-HEHS-96-212: Published: Sep 12, 1996. Publicly Released: Sep 12, 1996.

http://www.gao.gov/products/T-HEHS-96-212

http://www.gao.gov/assets/110/106648.pdf

“Too often we underestimate the power of a touch, a smile, a kind word, a listening ear, an honest compliment, or the smallest act of caring, all of which have the potential to turn a life around.”
 
― Leo Buscaglia

Medical Whistleblower Advocacy Network

MEDICAL WHISTLEBLOWER ADVOCACY NETWORK

P.O. 42700 

Washington, DC 20015

MedicalWhistleblowers (at) gmail.com

CONTACT


"Never impose on others what you would not choose for yourself."  Confucius

"It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood; who strives valiantly; who errs, who comes short again and again, because there is no effort without error and shortcoming; but who does actually strive to do the deeds; who knows great enthusiasms, the great devotions; who spends himself in a worthy cause; who at the best knows in the end the triumph of high achievement, and who at the worst, if he fails, at least fails while daring greatly, so that his place shall never be with those cold and timid souls who neither know victory nor defeat."

Theodore Roosevelt- Excerpt from the speech "Citizenship In A Republic", delivered at the Sorbonne, in Paris, France on 23 April, 1910