HCPro.com - Pharma Compliance Alert

Editor's Note: Final Issue of Pharma Compliance Alert

Wed, 13 May 2009 04:43:00 GMT

This will be the final issue of Pharma Compliance Alert. We thank you for being a loyal subscriber.

If you are interested in information about customizable, compliance e-learning courses for sales and marketing staff, please contact Maureen Croce at 866-464-2776 or mcroce@hcpro.com.

Vermont strengthens gift ban

Wed, 13 May 2009 04:41:00 GMT

The Vermont legislature is getting tougher on the pharmaceutical industry by passing a bill that tightens up the state’s existing gift and payment disclosure law.

The new law closes a trade secret loophole that allowed pharmaceutical companies to submit most data in aggregate form. The bill also expands the disclosure requirement to medical device and biologics manufacturers.

Read more about Vermont's updated gift ban.

No class action status in CA Vioxx lawsuit

Wed, 13 May 2009 04:39:00 GMT

Los Angeles Superior Court Judge Victoria G. Chaney denied class action status to plaintiffs seeking to sue Merck for its withdrawn painkiller Vioxx.

Chaney said in her ruling that trying plaintiffs’ claims would require an examination of each proposed class member’s medical needs and history, which Merck successfully argued would be unfair, according to a company statement.

Read more about Chaney's decision in the Vioxx lawsuit.

Editor's Note: Publication of Pharma Compliance Alert to end May 13

Wed, 06 May 2009 04:54:00 GMT

Next week’s issue will be the final issue of Pharma Compliance Alert. We thank you for being a loyal subscriber.

If you are interested in information about customizable, compliance e-learning courses for sales and marketing staff, please contact Maureen Croce at 866-464-2776 or mcroce@hcpro.com.

Ranbaxy recalls Nitrofurantoin

Wed, 06 May 2009 04:51:00 GMT

Ranbaxy Laboratories issued a voluntary recall for all 100 mg Nitrofurantoin Capsules currently on the market in the United States, the company announced.

Only some lots of Nitrofurantoin do not conform to approved laboratory specifications, but the company decided to recall all of the capsules. Ranbaxy said the capsules are unlikely to produce any serious adverse reactions, but may increase nausea and vomiting.

Michigan False Claims Act qualifies for additional recoveries

Wed, 06 May 2009 04:49:00 GMT

Michigan’s Medicaid False Claims Act meets the requirements of the Deficit Reduction Act of 2005 (DRA) and the state is entitled to an additional 10% of false claims recoveries, according to the OIG.

Under the DRA, each state with a False Claims Act that is at least as effective in facilitating and rewarding qui tam actions as the Federal False Claims Act in protecting state Medicaid funds is entitled to an extra 10% of fraud recoveries from those actions. For the state to receive the additional money, the OIG must approve the state’s False Claims Act.

IOM calls for end to industry support

Wed, 06 May 2009 04:46:00 GMT

The Institute of Medicine (IOM) became the latest organization to call for an end to pharmaceutical industry support for academic medical centers, journals, and professional societies.

The IOM wants entities engaged in health research, education, clinical care, and development to establish guidelines for accepting industry support and to strengthen conflict-of-interest policies, according to an IOM report.

Congress should also require pharmaceutical companies to publicly disclose payments to physicians, researchers, academic health centers, professional societies, patient advocacy groups, and others involved in medicine, IOM said.

Court upholds Vermont ban on data mining

Wed, 29 Apr 2009 04:57:00 GMT

Pharmaceutical companies may soon be unable to collect prescriber data in Vermont.

District Judge J. Garvan Murtha cleared the way for the state to enact a ban on the data-mining of prescription drug information for marketing purpose when he ruled the 2007 law that bans the practice is constitutional.

PhRMA revises guidelines for clinical trials

Wed, 29 Apr 2009 04:55:00 GMT

Pharmaceutical companies should provide results summaries for all interventional clinical trials involving patients, according to revised industry guidance.

Companies should publish the summaries whether the FDA approves the medicines or the particular research programs have been discontinued

Pharma companies spent almost $3M on marketing in Vermont for FY 2008

Wed, 22 Apr 2009 04:46:00 GMT

Pharmaceutical manufacturers paid almost $3 million to 2,280 doctors, hospitals, universities, and others to market their drugs in fiscal year 2008, according to the Vermont Attorney General’s (AG) sixth annual Report on Pharmaceutical Marketing Disclosures.

Almost half of the reported marketing expenditures were for speaking fees and payments, while nearly 25% was for marketing. Almost 60% of the expenditures were direct payments to recipients in the form of cash or check.

Genentech withdraws Raptiva

Wed, 22 Apr 2009 04:43:00 GMT

Genentech is voluntarily withdrawing its psoriasis drug Raptiva from the U.S. market because of the drug’s association with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system, the company announced.

Genentech estimates 2,000 patients in the U.S. take Raptiva for chronic plaque psoriasis and approximately 46,000 patients worldwide have been treated with Raptiva since 2003. Three patients receiving Raptiva were diagnosed with PML and a fourth developed progressive neurologic symptoms and died of an unknown cause.

Genentech advised physicians to stop writing Raptiva prescriptions for new patients and to work with patients currently taking the drug to find an alternative treatment. Raptiva will not be available after June 8.

AndroGel manufacturers accussed of delaying generics

Wed, 22 Apr 2009 04:39:00 GMT

Unimed Pharmaceuticals, Solvay Pharmaceuticals, Watson Pharmaceuticals, Par Pharmaceuticals, and Paddock Laboratories are facing allegations they conspired to keep generic versions of AndroGel off the market.

A lawsuit filed in New Jersey federal court claims the companies violated the Anti-Trust Act by agreeing to delay the release of generic versions of the testosterone replacement therapy. As a result, purchasers of the drug were overcharged millions of dollars, the suit claims.

The Federal Trade Commission filed a similar suit against Solvay, Watson, and Par in February.

Business associates: HIPAA survey

Wed, 22 Apr 2009 04:37:00 GMT

We want to hear from business associates about their need for HIPAA training. Business associates perform services on behalf of a covered entity that involve the use or disclosure of protected health information. If you work as an employee of a covered entity, please do not take this survey.

To thank you for participating in this survey, we will choose one person to win a $50 AMEX gift card.

Complete the survey.

Two pharma companies barred from manufacturing unapproved drugs

Wed, 15 Apr 2009 04:12:00 GMT

The FDA barred Neilgen Pharmaceuticals and its parent company, Advent Pharmaceuticals from manufacturing or distributing unapproved drugs, according to an agency release.

Neilgen and Advent manufacture and distribute more than 25 different unapproved drug products each. Most are prescription cough and cold products. Because these products have not gone through FDA testing, their safety and effectiveness is unknown. In addition, the FDA has not reviewed the adequacy and accuracy of the directions for use and warnings on the labeling.

Johns Hopkins, Partners HealthCare adopt new conflict-of-interest policies

Wed, 15 Apr 2009 04:07:00 GMT

Johns Hopkins Medicine (JHM) and Partners HealthCare are enacting new conflict-of-interest policies that will limit pharmaceutical representatives’ access to healthcare professionals.

Both new policies prohibit staff members from accepting gifts, including meals, from pharmaceutical company representatives.

FDA warns pharma companies for online ads

Wed, 08 Apr 2009 04:59:00 GMT

Fourteen pharmaceutical companies received warning letters from the FDA for “misleading” sponsored links on internet browsers.

The sponsored links are misleading because they make representations and/or suggestions about the efficacy of the products, but fail to communicate any risk information, according to the FDA letters.

GlaxoSmithKline, Forest Laboratories, Bayer, Cephalon, Pfizer, Novartis, Genentech, Boehringer Ingelheim, Merck, Eli Lilly, and Roche received warning letters for more than one product. Johnson & Johnson, Biogen Idec, and sanofi-aventis received warning letters for one product each. The FDA cited ads for a total of 48 products in the warning letters.

Former BMS exec pleads guilty to false FTC certification

Wed, 08 Apr 2009 04:56:00 GMT

Andrew Bodnar, a former senior executive with Bristol-Myers Squibb (BMS), pleaded guilty April 6 for making a false certification to the Federal Trade Commission (FTC) and will pay a $1 million criminal fine, according to a Department of Justice (DOJ) release.

Caraco recalls Digoxin tablets

Wed, 08 Apr 2009 04:53:00 GMT

Caraco Laboratories issued a recall for its Digoxin tablets because they may differ in size and therefore could have more or less of the active ingredient, according to an FDA release.

Physicians use digoxin to treat heart failure and abnormal heart rhythms. A higher than labeled dose may lead to digoxin toxicity in patients with renal failure, the FDA said. A lower than labeled dose may not be effective, potentially resulting in cardiac instability.

Caraco is recalling Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, that are not expired and are within the expiration date of September 2011.

Start preparing now for disclosures in Massachusetts

Wed, 08 Apr 2009 04:51:00 GMT

Beginning July 1, every pharmaceutical company must annually disclose to the Massachusetts Department of Public Health any payment or economic benefit with a value of at least $50 made in connection with sales or marketing activities.

“You have a year to do this, but you can’t get all of your data two days before the report is due and then say, okay, who’s going to start looking at what this all means,” says Kate Feola, Esq., an associate with McDermott, Will & Emory, LLP, in Washington, D.C. “It’s a good idea to start tracking it in real time and taking a look at what type of data you have, what category of reporting does it fall into, and get a good sense of what that information is that looking like on an overall basis.”

Download our free white paper, Massachusetts Disclosure Regulations: New Challenges for Pharmaceutical, Medical Device Manufacturers, to learn more about the new law and how your company can prepare for it.

BMS settles Plavix investigation

Wed, 01 Apr 2009 04:49:00 GMT

Bristol-Myers Squibb (BMS) will pay $2.1 million to resolve allegations it made false statements to the Federal Trade Commission (FTC) regarding its blood thinner Plavix, according to Bloomberg.com.

The FTC accused BMS of concealing material information about a failed 2006 agreement with Apotex, a Canadian generic drug manufacturer. BMS and partner Sanofi-Aventis agreed in 2006 to pay Apotex at least $40 million to keep a generic version Plavix off the market until 2011, as part of a patent dispute. However, the deal fell through when state attorneys general refused to approve it. BMS and Sanofi-Aventis won the patent suit in 2007.

BMS pleaded guilty to two violations of the federal False Statements Act and paid a $1 million fine in May 2007 for lying to the federal government about the proposed patent deal with Apotex. In December 2008, the company reached a $1.1 million settlement with all 50 states and the District of Columbia to resolve similar allegations.