Tag Archives: brand name drugs

Top Medicare Prescribers Collect Speaking Fees from Drug Makers-Coincidence?

LOL Blog Label 2By Lance O. Leider, J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A recent investigation by ProPublica found that certain doctors who prescribed certain drug brands the most, also have financial ties to the companies that manufacture those prescription drugs. Using Medicare payment data, ProPublica and National Public Radio (NPR) researched physicians who prescribed the most heavily promoted drugs of 2010 and 2011. It was discovered that many of the doctors allegedly had financial relationships with prescription drug manufacturers. ProPublica states that they initiated this investigation out of fear that pharmaceutical payments are influencing doctors to prescribe an expensive, brand name drug over a cheaper, generic version.

To read the ProPublica analysis released June 25, 2013, click here.

According to ProPublica, the company is an independent, nonprofit newsroom that produces investigative journalism in the public interest.

By The Numbers.

The ProPublica analysis looked at a number of drug companies. Until now, doctors’ prescribing practices have not been made public. Disclosure of these records is now mandated in the Affordable Care Act.

According to NPR, at least 17 of the 20 doctors who prescribed the blood pressure medicine Bystolic the most often collected money from the maker, Forest Laboratories. Forest paid those doctors speaking fees for promoting Bystolic at seminars to other doctors. These fees allegedly ranged from $1,250 to $85,750. Additionally, seven of the speakers allegedly received at least $1,000 for meals. Nine of the top 10 prescribers of Exelon, an Alzheimer’s drug, collected speakers’ fees from Novartis. Eight of the top 10 Nucynta prescribers were paid by the painkiller’s manufacturer, Johnson & Johnson, for similar services, according to NPR.

Click here to read the entire NPR article.

Drug Makers Shell Out Millions in Fines for Using Illegal Kickbacks.

Federal whistleblower lawsuits against several pharmaceutical companies have alleged that these speaking payments are little more than “thinly veiled kickbacks,” which are illegal. According to NPR, three years ago Forest paid $313 million to the federal government to settle allegations about its marketing of drugs. The lawsuit alleged the company made cash payments disguised as consulting fees to doctors.

Novartis is currently fielding two different lawsuits filed by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal kickbacks to pharmacists. A second lawsuit was filed on April 26, 2013, alleging illegal kickbacks were paid by Novartis to health care providers. According to the DOJ, the government’s complaint seeks damages and civil penalties under the False Claims Act, and under the common law for paying kickbacks to doctors to induce them to prescribe Novartis products that were reimbursed by federal health care programs.  Click here to read a previous blog on these lawsuits.

Individual providers are also liable for accepting prohibited remunerations from drug companies. The use of these databases for mining prescribing/promoting practices is likely to lead to increased scrutiny on physicians.

What the Law Says About Using Kickbacks.

For years drug companies have paid doctors to speak about new drugs at educational conferences with other health care professionals. The practice is legal, but considered questionable.

Under the Anti-Kickback Statute, it’s a felony for health care professionals to accept bribes in exchange for recommending a drug or service covered by Medicare, Medicaid, TRICARE or the Department of Veterans Affairs health care program.

Relationship Between Physicians and Pharmaceutical Companies Allegedly Does Not Influence Prescribing Practices.

In a survey, doctors said they are not influenced by relationships with pharmaceutical companies, according to a FiercePharma article. The doctors with a relationship to Forest state a number of reasons for prescribing Bystolic versus other blood pressure dugs. None of the reasons for prescribing Bystolic related to the money they received from Forest.

In the same FiercePharma article, drug makers said they do not choose speakers based on a doctor’s prescribing habits. Click here to read the FiercePharma article.

So is this all a coincidence?

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

Is it a coincidence that top prescribers also collect from drug makers? As a health care professional, would you be influenced to prescribe one drug if you were getting paid by the drug maker? Please leave any thoughtful comments below.

Sources:

Staton, Tracy. “Top-Prescribing Docs Collect Cash From Drugmakers.” FiercePharma. (June 25, 2013). From: http://www.fiercepharma.com/story/top-prescribing-docs-collect-cash-drugmakers/2013-06-25

Ornstein, Charles, Weber, Tracy and Lafleur, Jennifer. “Top Medicare Prescibers Rake In Speaking Fees From Drugmakers.” National Public Rado. (June 25, 2013). From: http://www.npr.org/blogs/health/2013/06/25/195232541/top-medicare-prescribers-rake-in-speaking-fees-from-drugmakers

Ornstein, Charles, Weber, Tracy and Lafleur, Jennifer. “Top Medicare Prescibers Rake In Speaking Fees From Drugmakers.” ProPublica. (June 25, 2013). From: http://www.propublica.org/article/top-medicare-prescribers-rake-in-speaking-fees-from-drugmakers

About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

George F. Indest III, Board Certified by The Florida Bar in Health Law

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

–  “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

–  “One who makes such a payment may be unable to explain and to justify it.”

–  “Such a firm or individual may well possess market power derived from the patent.”

–  “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

–  “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From: http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From: http://www.ftc.gov/opa/2013/06/actavis.shtm

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.