Amgen will not have to face a lawsuit from seven small health benefit plans that claimed the company improperly promoted its anemia drugs.
The U.S. District Court for the Central District of California dismissed the suit as an improper attempt to privately enforce the Food, Drug, and Cosmetic Act, according to a Reuters article. The court also ruled the plaintiffs needed to reference specific misrepresentations made by Amgen and two kidney dialysis providers.
Abbott’s American Academy of Dermatology post meeting news ad for HUMIRA misbrands the drug in violation of the Food, Drug, and Cosmetic Act, according to an FDA warning letter.
The ad suggests HUMIRA is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience. In addition, risk information presented in the ad is small and hard to read, while the efficacy presentation uses a large font size. Risk information must be as prominent and readable as information relating to the effectiveness of the drug.
Amgen and Immunex agreed to pay a combined $1.7 million to settle charges they defrauded Wisconsin’s state Medicaid program by publishing false average wholesale prices for their products, according to a Wisconsin Department of Justice (DOJ) press release.
The DOJ filed suit against 36 pharmaceutical companies accusing them of reporting inflated average wholesale prices to pricing compendia for identified drugs. The Medicaid program utilized the compendia for the payment or reimbursement of pharmacists for Medicaid recipients and consequently paid substantially more than the actual cost of the drug.
The payment will go back to Medicaid. The companies also agreed to pay $300,000 to cover legal costs and fees. Amgen acquired Immunex in 2001.
The trial of another of the named defendants, Pfizer’s Pharmacia unit, is scheduled for February 2009.
The FDA updated and clarified in new draft guidance the procedures for reviewing pre-market notification submissions [510(k)s] for devices labeled as sterile.
The guidance provides details about the pyrogenicity information manufacturers should include in 510(k) submissions and provides information about the sterilization processes recommended by the FDA. It includes information about traditional, non-traditional, and novel non-traditional sterilization methods.
The guidance does not cover the sterilizers themselves or 510(k) submissions for reusable medical devices, 510(k) submissions for reprocessed single-use devices, or information to be included in 510(k)s for devices that contain animal tissue.
Healthcare industry credentialing requirements place a financial and administrative burden on medical device companies. The requirements can also raise kickback concerns.
Hospitals often require companies to pay access or badge fees. Because the medical device manufacturer is paying a customer for access to the facility, the company could be accused of paying kickbacks. These fees are not standardized, so they can vary greatly from one hospital to another. This difference in the amount paid can also raise kickback red flags.
Many sales representatives call on more than one hospital, which creates an administrative nightmare and increases Anti-kickback Statute liability. Hospitals call the credentialing fees necessary and reasonable.
Our free white paper provides more information about credentialing, as well as tips for how to meet credentialing requirements.
The Federal Trade Commission (FTC) filed suit in U.S. District Court in Minnesota against Ovation Pharmaceuticals, alleging the company created a monopoly and then forced hospitals to pay drastically increased prices.
The FTC claims the company purchased the rights to two pharmaceuticals used to treat a potentially fatal congenital heart defect in premature infants, then raised the price 1,300%.
The FTC wants Ovation to divest one of the two drugs and forfeit what it calls “unlawfully obtained profits.” The Minnesota attorney general also filed suit against the company.
In a statement, the company said it strongly disputes the FTC’s allegations, adding that the two products are not interchangeable in most premature infants.
The Texas attorney general alleges Janssen Pharmaceutica used kickbacks and false marketing to defraud the state’s Medicaid agency, according to a new filing.
According to the filing, Janssen paid kickbacks and distributed false marketing materials for its schizophrenia drug, Risperdal, to get the drug on Texas’ list of preferred Medicaid drugs. The state claims the company paid third-party contractors and nonprofit groups to promote Risperdal and create the impression the drug was widely supported. In addition, Janssen allegedly compromised the objectivity of scientists performing research by providing them with funding, consulting fees, extravagant meals and travel.
A Janssen spokesperson said the allegations have no merit and the company only promotes products for FDA-approved uses, according to a Dallas Morning News article.
A Victory Pharma sales aid minimizes risks, presents misleading safety information, and omits important risk information associated with the use of Xodol, according to an FDA warning letter.
According to the FDA, the sales aid also suggests that Xodol is safer and effective for use under broader conditions than has been demonstrated by substantial evidence or substantial clinical experience.
A Minnesota state senator would like to see the state’s disclosure law expand to include medical device companies, according to a Minneapolis Star-Tribune article.
In 1993, the state passed a bill requiring pharmaceutical companies to disclose payments to physicians and other healthcare professionals. Senator John Marty introduced a new bill last year that would require medical device manufacturers to disclose payments made to healthcare professionals and would ban industry gifts to healthcare professionals.
Under the bill, medical device manufacturers would not have to disclose payments for legitimate clinical research that does not exceed a set hourly rate and reasonable honoraria for healthcare professionals who speak at professional or educational conferences.
The Massachusetts Public Health Council recently released draft regulations that would require the disclosure of fees, payments, and other compensation by medical device manufacturers to healthcare providers. Congress is also considering the Physician Payments Sunshine Act, which would require that pharmaceutical and medical device manufacturers disclose all payments to physicians.
Massachusetts will become the most restrictive state for pharmaceutical marketing if regulations proposed by the Massachusetts Public Health Council are adopted, according to a council press release.
The regulations are designed to regulate pharmaceutical and medical device manufacturers’ sales and marketing practices and mandate disclosure of compensation paid to healthcare professionals.
Under the new rules, pharmaceutical and medical device manufacturers may not provide:
- Reminder items such as pens, mugs, and notepads
- Entertainment and recreation
- Payments to healthcare providers except as compensation for bona fide services
Pharmaceutical and medical device manufacturers would be required to disclose all payments of more than $50 except payments made to healthcare providers for genuine research projects and clinical trials.