20 US States Filed Lawsuit against Heritage Pharmaceuticals, (part of Pune/Indian company-Emcure Pharmaceuticals for price manipulation
Price-fixing and manipulation Case
PRICE $3-$4 drugs increase to $191.00 and $27.00 increase to $1849
Los Angeles. Dec. 16, 2016
NRIpress.club/Ramesh/Dr. S.Saini/Gary Singh Grewal
Attorney General George of Connecticut, Jepsen joined with 19 other state attorneys general in filing a federal lawsuit against generic drug-makers Heritage Pharmaceuticals, Inc. as a "ring leader" of the price manipulation; Aurobindo Pharma USA, Inc., Citron Pharma, LLC, Mayne Pharma (USA), Inc., Mylan Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. alleging that they entered into illegal conspiracies in order to unreasonably restrain trade, artificially inflate and manipulate prices and reduce competition in the United States for two drugs: doxycycline hyclate delayed release, an antibiotic, and glyburide, an oral diabetes medication.
According to Bloomberg news media:
- Mylan NV was the dominant producer of a high-price, delayed-release version of doxycycline hyclate
- Heritage also makes a delayed-release version of the antibiotic.
“While the principal architect of the conspiracies addressed in this lawsuit was Heritage Pharmaceuticals, we have evidence of widespread participation in illegal conspiracies across the generic drug industry. Ultimately, it was consumers – and, indeed, our healthcare system as a whole – who paid for these actions through artificially high prices for generic drugs. We intend to pursue this and other enforcement actions aggressively, and look forward to working with our colleagues across the country to restore competition and integrity to this important market.”
Heritage is the exclusive US commercial footprint for Emcure Pharma Ltd. (India). A spokesman for Heritage referred to their comment from the previous day, which blamed the former executives for the price-fixing and said that they had been terminated.
Heritage Pharmaceuticals Inc. is a rapidly expanding specialty pharmaceutical company focused on the acquisition, licensing, development, marketing, sale, and distribution of both generic and legacy branded pharmaceutical products for the US prescription drug market. Founded in 2006, Heritage currently markets 40 generic prescription products within a portfolio of 120 SKUs. Heritage utilizes an integrated global supply network that leverages exclusive access to FDA-approved manufacturing and development facilities in both North America and Asia, including active pharmaceutical ingredients and finished dosage forms across oral solid, injectable, and cytotoxic capabilities.
On July 2, 2013, Heritage Pharmaceuticals Inc. announced the immediate availability of Doxycycline Hyclate delayed-release tablets in 75-, 100-, and 150-mg strengths. This product is the AB-rated generic equivalent to the antibiotic drug Doryx®† and adds to Heritage’s robust portfolio of high-barrier, extended-release, oral solid products. According to IMS data for the 12 months ended May 2013, the US market for Doxycycline Hyclate approximated $160 million.
†Doryx is a registered trademark of Warner Chilcott.
As one of the Emcure group companies, Heritage works in close cooperation with Emcure’s global R&D and business development teams to optimize strategies for product pipeline selection and continued product acquisition across all product dosage forms. Most recently, Emcure-Heritage acquired the global rights to an exclusive oncology brand product, BiCNU®
· In 2014, the state of Connecticut initiated an investigation of the reasons behind suspicious price increases, long-running conspiracy to fix prices and allocate markets for doxycycline hyclate delayed release and glyburide.
· The states further allege that the drug companies knew that their conduct was illegal and made efforts to avoid communicating with each other in writing or, in some instances, to delete written communications after becoming aware of the investigation.
· The states allege that the companies’ conduct violated the federal Sherman Act and are asking the court to enjoin the companies from engaging in illegal, anticompetitive behavior and for equitable relief, including substantial financial relief, to address the violations of law and restore competition
The Justice Department has asked the judge in that case to put it on hold as prosecutors pursue their investigation.
“We are fully cooperating with all aspects of the Department of Justice’s continuing investigation,” Heritage said in a written statement. “Recently Heritage initiated its own legal action against these same individuals to seek redress for an elaborate embezzlement and self-dealing scheme. We are deeply disappointed by the misconduct and are committed to ensuring it does not happen again.”
The other drugmakers:
- Nina Devlin of Mylan denied the charge
- Teva spokeswoman Denise Bradley said by email that the company had just received the complaint and was reviewing it.
The other three companies had no immediate comment.
Generic drug pricing became an issue in 2014, driven in large part by media reports of sharply rising drug prices, and Congress opened an investigation.
The other states involved are Delaware, Florida, Hawaii, Idaho, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Nevada, New York, North Dakota, Ohio, Pennsylvania, Virginia and Washington.
New York Attorney General Eric Schneiderman said, "Companies that collude and fix prices for generic drugs in order to pad their profits must be held accountable for the very real harm they inflict on New Yorkers' ability to pay for life-saving medications."
In 2015, generic drug sales in the United States were estimated at $74.5 billion.
Shares fell among drugmakers that have disclosed receiving subpoenas related to the probe.
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Department of Health and Human Services
Public Health Service
Food and Drug Administration
New Jersey District
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
November 5, 2015
VIA UNITED PARCEL SERVICE
Mr. Jeffrey A. Glazer
Vice Chairman, Chief Executive Officer
Heritage Pharmaceuticals, Inc.
12 Christopher Way Ste 300
Eatontown, NJ 07724
Dear Mr. Glazer:
Between May 12, 2015 and May 27, 2015, the U.S. Food and Drug Administration (FDA) inspected your firm, Heritage Pharmaceuticals Inc., located at 12 Christopher Way, Eatontown, New Jersey. The inspection revealed serious violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements under Section 505(k) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 355(k)] and Title 21, Code of Federal Regulations (21 CFR) 314.80 and 314.98. Failure to comply with Section 505(k) is a prohibited act under Section 301(e) of the Act [21 U.S.C. § 331(e)].
We acknowledge receipt of your written response dated June 16, 2015 to the Form FDA 483, Inspectional Observations, issued to your firm on May 27, 2015. From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your firm's written response, we conclude that your firm did not adhere to the applicable statutory requirements and FDA regulations governing PADE reporting. Specific violations include, but are not limited to, the following:
1. Failure to report each adverse drug experience not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals for three years from the date of approval of the application, and then at annual intervals, as required by 21 CFR 314.80(c)(2)(i) and 21 CFR 314.98(a).
As the holder of abbreviated new drug applications (ANDAs), you are required to submit Periodic Adverse Drug Experience Reports (PADERs) for each application. PADERs are required to include all adverse experience reports not reported as 15-day Alert reports. Between 2010 and 2014, your firm failed to submit approximately (b)(4) individual case safety reports (ICSRs) required to be submitted with their respective quarterly and/or annual PADERs, affecting at least (b)(4) applications held by your firm.
For example, for (b)(4), the annual PADERs for the time periods 06/2010 through 06/2014 state, "No adverse drug experience reports were received for this product during this reporting period." However, there were approximately ten ICSRs reported to your firm during that period of time that should have been included in the corresponding PADERs. This omission was not discovered by your firm until it was pointed out by the FDA investigator during the inspection.
Your management indicated that PADERs were prepared for your approved applications by a regulatory affairs contractor and that the contractor should have known to include ICSRs in their respective PADERs. As the application holder, you are ultimately responsible for all PADE submissions and recordkeeping requirements under the Act and implementing regulations. The complete omission of ICSRs required to be submitted with PADERs for a period of over four years raises concerns about your firm's ability to monitor the safety of drug products.
Your response to this observation has been reviewed and determined to be inadequate. In your response, you committed to submitting to the Agency amended PADERs for the affected applications to include the non-expedited ICSRs omitted from your PADERs. Your response is inadequate because we cannot determine whether you have implemented adequate preventative measures, such as adequate SOPs, work instructions, database access, and staff training, to prevent recurrence of your failure to submit non-expedited ICSRs in their respective PADERs in the future. This is particularly concerning as we note that your firm's Standard Operating Procedures (SOPs) in effect at the time of the inspection fail to include any provisions on the completion, evaluation, and submission of accurate PADERs.
2. Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences from all sources as required by 21 CFR 314.80(b) and 21 CFR 314.98(a).
Your firm does not have adequate written procedures to ensure that adverse drug experiences are correctly assessed and reported to FDA in accordance with postmarketing regulations. During the inspection you provided your firm's two SOPs pertaining to PADE requirements: (b)(4)
Your firm's SOPs fail to ensure that: (1) all ADE information obtained from all sources is promptly conveyed to the appropriate Heritage personnel and reviewed, (2) all ADEs are evaluated against the U.S. package insert for seriousness and expectedness, (3) all ADEs are reported accurately from source documentation to the FDA, (4) all ADEs that are the subject of 15-day Alert reports are promptly investigated and all attempts to obtain additional information about the adverse experiences are recorded, and (5) a Form FDA 3500A for each ADE not reported as a 15-day Alert report under 21 CFR 314.80(c)(1)(i) is timely submitted in the correct format.
e also note that your (b)(4) states that you will retain ADE records for not less than three years. A three-year record retention period is inconsistent with the ten-year record retention period required by postmarketing regulations under 21 CFR 314.80G). We believe the inadequacy of your SOPs contributed to your firm's failure to submit over (b)(4) ICSRs with their associated PADERs, affecting at least (b)(4) ANDAs. We acknowledge that this violation, as written, was not included on the Form FDA 483 that you received.
Without adequate written procedures, we cannot be assured that you will accurately capture and report important safety information about your drug products to FDA. Failure to report ADEs to FDA at the required intervals raises concerns about your firm's ability to monitor the safety of drug products, as well as the reliability and integrity of the information submitted to FDA.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your firm. It is your responsibility to ensure compliance with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action, including injunction, without further notice. Federal agencies are advised of the issuance of all Warning Letters about drugs and devices so that they may take this information into account when awarding contracts. FDA may re-inspect your firm to verify corrective actions have been completed.
If, as a result of receiving this warning letter or for other reasons, you are considering a decision that could reduce the number of active pharmaceutical ingredients and/or finished products produced by your manufacturing facility, FDA requests that you contact CDER's Drug Shortages Staff immediately, as you begin your internal discussions, at firstname.lastname@example.org so that we can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances in your drug manufacture under 21 U.S.C. 356C(a)(1) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. In appropriate cases, you may take corrective action without interrupting supply, or to shorten any interruption, thereby avoiding or limiting drug shortages.
Within fifteen working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. You may wish to include dates for when each corrective action will be fully implemented.
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer by telephone at 973-331-4904.