Health Care Reform Strengthens Fraud Prosecutions and Expands Scope of False Claims Act

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The Patient Protection and Affordable Care Act, signed into law on March 23, 2010, will make it easier for the federal government to investigate and prosecute health care fraud and increase penalties for violations. The new bill provides for more than $350 million over 10 years to reduce healthcare fraud and abuse while easing prosecutions, strengthening sentencing guidelines, and expanding the False Claims Act.

The bill eliminates the need for prosecutors to prove actual knowledge of or specific intent to violate the law under the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b) and the federal health care fraud statute (18 U.S.C. § 1347). The Bill is likely in response to the 9th Circuit Case, Hanlester Network v. Shalala, which provided for heightened standards of intent. Prosecutors will also be able to issue administrative subpoenas for the production of documents.

Kickbacks and offenses in violation of Section 301 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 331) will now be considered Federal Health Care Fraud Offenses. Further, those suspected of obstructing a criminal investigation of federal health care fraud may have their assets frozen, while those who obtain property from the commission of fraud w have their personal property subject to forfeiture.

The bill will also change the definition of “intended loss” under the Federal Sentencing Guidelines. Section 2B1.1(b)(1) of the guidelines provides that the loss from fraud is calculated as either the actual loss or intended loss whichever is greater. While courts in the past have calculated “intended loss” as the amount actually paid by the government or payable under government fee schedules, the new bill allows for the dollar amount of fraudulent bills submitted to constitute prima facie evidence of intended loss. The result will be heightened sentencing for white collar criminals in health care. Further, the statute will increase the offense level for defendants convicted. Changes include:
¢ A two-level increase in the offense level for losses of $1 million or more.
¢ A three-level increase in the offense level for losses of $7 million or more.
¢ A four-level increase in the offense level for losses of $20 million or more.

The False Claims Act will also be strengthened by the reform statute. Claims arising from a violation of the Ant-Kickback statute will now expressly constitute violations of the False Claims Act, regardless of whether the wrongdoer submits the claim. The bill also strengthens the Act by allowing for whistleblowers to bring suits and restricting the public disclosure bar (providing that disclosures made in criminal, civil or administrative hearing or in government reports, hearings, audits and investigations bar a federal FCA suit) to federal government hearings, reports, audits and investigations. Finally, the FCA will be applicable to payments made by the American Health Benefit Exchanges if they include federal funds and civil penalties for exchange-related FCA liability will be 3 to 6 times the amount of damages.

Additional Provisions include:
¢ The ability to suspend pending Medicare and Medicaid payments to providers and suppliers pending investigations into allegations of fraud.
¢ Civil monetary penalties for knowingly making false statements to enroll as a provider or supplier in a federal health care program.
¢ Mandatory compliance programs for providers and suppliers.
¢ HHS oversight of Medicaid and Medicare Parts C and D.
¢ Exclusions from Medicaid for companies or individuals that control entities that have not repaid overpayments, have been suspended, terminated, or excluded from participation, or are affiliated with an entity that has.
For more information regarding Health Care Reform please contact us at contact@fidjlaw.com.

Judge Agrees Agency for Health Care Administration Rule Goes Beyond Regulatory Powers

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On July 23, 2010, Administrative Law Judge Eleanor M. Hunter entered a Final Order in the case of Las Mercedes Home Care Corp v. Agency for Health Care Administration. The Order declared invalid a rule requiring Medicaid providers of home health agencies to issue either W-2 or 1099 tax forms to individuals on their staffs.

Las Mercedes is a licensed home health agency in Florida and was an enrolled Medicaid provider of home health services from July 1, 2004 through June 30, 2006. The company works with patient physicians to determine the type and scope of home health services needed and arranges for such services to be provided through one of 22 companies with which it maintains staffing agreements.

The suit began in response to a September 30, 2008, Final Audit Report issued by ACHA which sought $878,843.93 in Medicaid overpayments and a fine of $1,000. Soon afterwards, Las Mercedes requested an administrative hearing and the case was referred to the Division of Administrative Hearings (DOAH) in November and set for hearing in February. Following numerous continuations, the AHCA Motion to Amend Final Audit Report was granted on June 24, 2009.

After additional discovery, Las Mercedes filed a Motion to Dismiss arguing that the AHCA rule requiring that Medicaid home health agencies issue W-2 or 1099 forms to individuals conflicted with Statutory authority. In response to an AHCA objection to consideration of the validity of the rule, Las Mercedes filed a rule challenge case; the two cases were then consolidated.

The challenged rule is a provision from the Florida Medicaid Home Health Services Coverage and Limitations Handbook, which has been incorporated by reference by Florida Administrative Code Rule 59G-4.130. The rule requires Home Health services to be provided by professionals who are directly employed by or under contract with a home health agency enrolled in Medicaid Home Health Services program and provides, “Employed or contracted means that the home health agency provides a W-2 of 1099 tax form for the individual.”

Attorney Andrew Ittleman of Fuerst Ittleman, on behalf of Las Mercedes, alleged that the Rule was an invalid exercise of AHCA authority because it (1) went beyond AHCAs powers, (2) contradicted the Florida Statute 400.463(9) definition of “employed by or under contract with” and (3) was arbitrary and capricious.

After determining that the DOAH had jurisdiction to determine the validity of Medicaid rules, the court found that none of the purported statutes authorized AHCA to regulate the business relationship between a home health agency and its employees or contractors. Accordingly, the Court held that the Rule goes beyond the scope of AHCA powers.

The court then found that the “direct employee” definition provided in Section 400.462(9), which includes, “an employee for whom a management company that has a contract to manage the home health agency on a day-today basis…” contradicted and precluded the AHCA definition of the same term. Further, there was no indication that the Legislature or federal government had intended for the AHCA to create its own more restrictive definition.

Finally, the court ruled that the additional requirement under the AHCA Rule was an irrational and illogical methodology for ensuring health, safety, and welfare, and curbing fraud, waste, and abuse. Thus, the court voided the rule established on page 1-8 of the Florida Medicaid Home Health Services Coverage and Limitations Handbook as an invalid exercise of delegated legislative authority.

For more information regarding the AHCA, Medicaid, or administrative agency regulations please contact us at contact@fidjlaw.com.

Dietary Supplement Marketer to Pay $5.5 Million to FTC for Weight Loss and Immunity Claims

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Weight loss, immunity, and cold and flu claims are on the radar of the Federal Trade Commission (FTC), as evidenced by last weeks $5.5 million settlement with supplement marketer, Iovate Health Sciences, U.S.A.  The FTC charged Iovate and two of its Canadian affiliates (Iovate Health Science Group, Inc. (now known as Kerr Investment Holding Corp.), and Iovate Health Sciences, Inc.) with deceptively advertising that its supplements “ Accelis and nanoSLIM “ could help consumers lose weight rapidly.  These same three companies also advertised that their Cold MD, Germ MD and Allergy MD products could treat or prevent colds, flu, allergies and hay fever, claims the FTC alleged were deceptive as well.

The FTC believed that Iovates “clinically proven” efficacy claims for the cold, flu and allergy formulas amounted to deceptive advertising.  Iovates claims that its weight loss products are “scientifically proven to speed up the metabolism,” could allow users to “lose 32 lbs fast” or lose weight at a rate of “one to two pounds per week” were similarly deceptive according to the FTC.  Additionally, the FTC found that some of the claims were deceptively delivered by actors portraying doctors, complete with white lab coats and stethoscopes; and by testimonials touting atypical weight loss results.  The FTC felt the claims were not merely deceptive and misleading but were outright false and further charged that Iovate knew of their falsity at the time the claims were being made. 

In settling with the FTC, Iovate did not admit to any wrongdoing; however, as part of the settlement, Iovate agreed that it would possess two adequate, well-controlled human clinical studies prior to making any future weight loss claim, and procure pre-approval from the U.S. Food and Drug Administration (FDA) before making any claims regarding the diagnosis, treatment, cure or prevention of any disease.

The settlement piques interest for two reasons.  First, it requires that Iovate seek FDA approval on efficacy claims.  While FDA approval can be required for certain health claims, it is an undertaking rarely required under FTC law.  Secondly, it demonstrates that the FTC is keeping a watchful eye on the supplement industry, an industry that has grown and flourished during the recent recession as many people are turning to alternative therapies and supplements rather than incurring the cost of doctors visits and allopathic medical products.

Senate Bill Introduced to Increase FDA Authority

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August 5, 2010

This week Sen. Michael Bennet (D-CO) introduced the Drug Safety and Accountability Act of 2010 to the U.S. Senate. The Bill aims to increase the authority of the U.S Food and Drug Administration (FDA) to regulate drugs manufactured overseas and allow for heightened oversight and regulation of over-the-counter (OTC) drugs.

Bennets Press Release explains, “For too long, the FDA has lacked the proper authority to adequately safeguard our drug supply and protect Colorado consumers. Its time Washington took acting to ensure the medicines Coloradans rely on are safe, and that those entrusted with the responsibility of developing these drugs are equipped to keep consumers out of harms way.”

The Bill was introduced the same day the Pew Prescription Project released poll results indicating that nine in ten voters support new safety measures for prescription drugs. The report also revealed that U.S. consumers have low confidence in the safety of drugs manufactured abroad, especially those produced in China and India.

The FDA has indicated support for the reforms, with Principal Deputy Commissioner Joshua Shafterstein stating that he believes the FDA needs authority to issue mandatory drug recalls. Additionally, The Pew Prescription, AARP, American College of Physicians, Consumers Union, Society of Chemical Manufacturers and Affiliates, the Community Catalyst, and others have issued a joint letter to Congress in support of the Bill. Proponents of the Bill estimate that 80% of active ingredients in U.S. pharmaceuticals are made abroad. Proponents, including the Bills sponsor, also note the 1,742 drug recalls implemented in 2009, which represents a 400 percent increase over 2008.

The new Bill would provide the FDA with additional recall power and enforcement options along with better tools to look into possible drug quality and safety issues including:
¢ Authority to assess civil penalties for Food, Drug and Cosmetic Act violations.
¢ Authority to subpoena documents and witnesses.
¢ Increased ability to exchange information between the FDA and other regulatory agencies.
¢ Ability to protect industry whistleblowers who bring information to the FDA.

The Bill would also increase manufacturer standards by:
¢ Requiring Companies to institute quality management plans to insure quality and safety of their drug components.
¢ Requiring companies to increase supplier oversight and document entities involved in supply chain for drug manufacturing

Finally, the Bill aims to increase oversight of over-the-counter medications by re-assigning them from a lower-risk category for inspection.

This Senate Bill comes only two weeks after House Representative Ed Towns (D-NY), Chair of Committee on Government Oversight and Reform, introduced the FDA Mandatory Recall Bill, also intended to increase FDA power. The House Bill, introduced July 15, would allow for the FDA to implement a quicker and more thorough recall process than the voluntary recall process currently in place. If the House Bill passes, the FDA will have the ability to order mandatory recalls for adulterated or misbranded drugs or drugs which pose a considerable risk of death or serious health consequences. The Bill was referred to the House Committee on Energy & Commerce.

The House Bill was introduced the same day Johnson & Johnson submitted a plan to correct problems at a Tylenol plant. The plan was required by the FDA after an April 30th cite check found numerous violations of good manufacturing conditions. The cite check coincided with recalls issued for Benadryl, Motrin, Tylenol, and Zyrtec for infants and children because of possible metallic particle contamination. The plan included new equipment and operations procedures.

For more information regarding current FDA authority, procedure, or regulations please contact us at contact@fidjlaw.com.

Feds Challenge Stem-Cell Treatment

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WASHINGTON (CN) – The Department of Justice says a stem-cell treatment to rebuild hips, knees and other joints has been misbranded by its manufacturer, Regenerative Sciences, and violates standards of the federal Food, Drug, and Cosmetic Act.

Colorado-based Regenerative Sciences calls the cultured stem cells used in the company’s Regenexx procedure a “cultured cell product,” while the FDA claims the cell product should be considered a drug. The Regenexx procedure involves taking cells from a patient’s bone marrow, processing the cells with the patient’s blood, then reinjecting the “product” into the patient.

The cultured cells should be classified as a drug, the government says, as they end up in a syringe to be injected back into the patient.

“Defendant’s cultured cell product is a ‘drug’ within the meaning of the FDCA, because Defendant’s labeling and promotional literature, including information contained on Regenerative Sciences’ website, establish that their cultured cell product is intended to be used in the cure, mitigation, and treatment of diseases in man and to affect the structure and function of the body,” says the government in its complaint.

Dr. Christopher Centeno, Regenerative Sciences’ acting CEO and defendant in the case, disputes the FDA’s claims that the product is a drug.

“This is about patients. We don’t dislike [the FDA] and respect its authority over drug production. However, we also believe a physician has the right to use stem cells or other body parts to help heal the patient, especially when it’s a better alternative to more invasive procedures,” says Dr. Centeno.

He says making a patient’s own stem cells a drug “won’t add measurable safety, but it will hugely increase cost and delay helping patients find better options for their medical problems.”

According to the FDA, if the cultured cell product is a drug, then Regenerative Sciences is not following the guidelines of “current good manufacturing practice.” The agency says its nearly two-month investigation of the company’s Colorado facilities “showed that the methods used in, and the facilities and controls used for, the manufacture, processing, packing, or holding of the cultured cell product do not conform to and are not operated or administered in conformity with current good manufacturing practice.”

Among the violations, the FDA says, Regenerative Sciences failed “to perform appropriate laboratory testing of each batch of drug product required to be free of objectionable microorganisms.”

The government says the company promised to correct some violations, “but they refused to correct many others because they do not believe that Regenerative Sciences is a drug manufacturer.”

“Regenerative Sciences has had an exemplary safety record, showing that our procedure is far safer than the knee replacements it has helped patients avoid,” Centeno says.

The company has sued the FDA four times in two years, trying to get a decision that the cultured cell product is “the practice of medicine” and not a drug, he explained in an interview with Courthouse News.

Colorado Medical Clinic Welcomes Opportunity to Fight FDA in Court

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Clinic Claims FDA Has Repeatedly Overstepped Regulatory Authority

DENVER, Aug. 9 /PRNewswire/ — Regenerative Sciences, Inc., a Colorado medical practice that specializes in the use of a person’s own stem cells to help patients avoid more invasive orthopedic surgery, announced today that the US Food and Drug Administration (FDA) is seeking to enjoin the clinic physicians from practicing medicine using patients’ own stem cells. The lawsuit will allow Regenerative Sciences to question the FDA’s policy that adult stem cells can be classified as drugs when used as part of a medical practice.

“The FDA will finally answer our questions, in court, about their claims and jurisdiction as opposed to doing everything in their power to avoid the issue that we are not a drug manufacturer, but simply a medical practice,” said Christopher Centeno, M.D., Regenerative Sciences’ medical director.

The FDA claims that Regenerative Sciences is using an “adulterated” product because it fails to follow mass manufacture guidelines in its medical practice that is applied to drug factories producing millions of doses. Rather than mass producing drugs, Regenerative Sciences uses the patient’s own stem cells to treat common orthopedic problems. Regenerative Sciences has had an unblemished safety record, recently publishing a large study showing that its procedure is dramatically safer than the traditional surgical procedures it has helped many patients avoid. Regenerative Science’s lab has strictly adhered to the International Cellular Medicine Society’s (ICMS) strict, professional guidelines and has been audited three times by independent third parties with no serious safety concerns.

“ICMS lab guidelines are the best fit for autologous cell processing and provide strong patient protection. If the FDA had any valid concerns about our medical practice not using drug factory guidelines, they knew about that in Spring of 2009 and did nothing. They did nothing because there were no safety issues. Their focus on this now is litigation posturing,” stated Centeno.

Regenerative Sciences has been using its patients’ stem cells to treat orthopedic conditions since 2005 and received an untitled letter from the FDA in 2008 claiming its medical procedure was creating a new biologic drug. The FDA inspected Regenerative Science’s facility in 2009, and found, at that time, that it was not compliant with drug mass manufacture guidelines, but failed to take any action.

Regenerative Sciences has filed two lawsuits against the FDA in an effort to force the organization to respond to questions about their jurisdiction in the matter. The medical practice filed a suit in Denver District Court in 2008 based on the issue that the FDA regulations regarding creating a drug out of the patient’s own stem cells exceeded the FDA’s congressional authority and that the Food, Drug, and Cosmetic Act contains exemptions for physicians using innovative therapies that do not go through FDA approval as part of their medical practice. Last month, Regenerative Sciences was forced to file suit against the FDA again, this time seeking a Temporary Restraining Order (TRO) to prompt the FDA to take “final agency action” or leave its medical practice alone following an exhaustive inspection of Regenerative Science’s facilities and taking no action.

“For two years we’ve been prodding the FDA to respond to our questions about how it has the ability to regulate a medical practice, so we’re encouraged that, as a result of this recent suit, the courts will decide if it the FDA has regulatory authority over the adult stem cells that live in everyone’s body,” stated Centeno. “This is an important case for everyone that suffers from any type of illness, not just patients with orthopedic problems. It will decide, once and for all, if the government has the right to restrict a patient and their doctor from using a person’s own stem cells to treat disease. Regenerative Sciences believes that stem cells are body parts and not the property of the government or big pharma.”

Adult stem cells are those found throughout the patient’s body. Recent medical research has indicated these important cells have as much clinical promise as the more controversial embryonic stem cells (cells taken from an embryo).

“What we’re doing in our Colorado medical practice is no different, in principle, than a fertility clinic that uses the in-vitro fertilization technique. The only difference is that we’re using stem cells and fertility clinics use fertilized eggs,” stated John Schultz, M.D., one of the founders of the Centeno-Schultz Clinic.

The FDA’s lawsuit is being closely monitored by the International Cellular Medicine Society (ICMS), a global nonprofit dedicated to patient safety and education in the medical use of adult stem cells that represents over 1,000 physicians, researchers and patients from over 35 countries on 6 continents. ICMS executive director, David Audley, stated “The Centeno-Schultz Clinic meets our strict criteria for the safe therapeutic use of adult autologous stem cells. There is more medical and scientific evidence supporting this type of medical therapy for orthopedic conditions, for example, than there is for many approved drugs that the FDA allows to be used in off-label or unconventional applications.”

About Regenerative Sciences

Headquartered in Colorado, Regenerative Sciences, Inc. is an extension of the medical practice of the Centeno-Schultz clinic and is focused on the development of the Regenexx┞¢ procedure, a breakthrough non-surgical option for people suffering from various orthopedic disorders. The physicians at Regenerative Sciences have developed a patent-pending procedure that uses a person’s own stem cells and blood growth factors to help regenerate bone and cartilage. Regenerative Sciences believes in educating patients, providing choices, offering options and encouraging people to take an active role in their own treatment. More information can be found at http://www.regenexx.com

SOURCE Regenerative Sciences, Inc.

RELATED LINKS
http://www.regenexx.com

When Export “Classification Determinations” do not Determine Anything At All

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In the August 2, 2010 edition of the Federal Register, the Bureau of Industry and Security (BIS) “ the Department of Commerces group in charge of export regulation in that department “ issued an interim final rule in which it says that exporters cannot rely on BISs classification determinations as “U.S. Government determinations.”

This seemingly convoluted bit of government semantics is designed to more effectively communicate to exporters what BIS has been saying for years:  Commerce isnt the only federal department or agency enforcing regulations.  In fact, BIS only has jurisdiction over those items and activities that are subject to the Export Administration Regulations (EAR).”  Therefore, when merchandise being exported falls clearly and solely under BIS jurisdiction, then its classification determinations are as good as gold.

But what happens when merchandise being exported falls under the jurisdiction of State Department’s Directorate of Defense Trade Controls (DDTC), or Treasurys Office of Foreign Assets Controls, or the Department of Energy or Nuclear Regulatory Commission?  Too often in the past, exporters have turned to BIS to pass judgment on products that arent “subject to the EAR.”  In those instances, exporters must comply with the regulations administered by the applicable agency, and exporters dont have to consider the provisions of the EAR.

So what are exporters supposed to do?  Government regulations state that an exporter should review relevant government regulations and make “jurisdictional determinations” as to which department or agency has primacy with respect to regulating a product.  In practice “ and when in doubt “ we encourage exporters to seek advisory opinions from BIS and the State Department as to the proper classification of merchandise.  When contacting the DDTC, exporters should request a “commodity jurisdiction” determination to ascertain an item is subject to the International Traffic in Arms Regulations (ITAR).

Armed with this self-determination of which agency or department has possible jurisdiction over a product, and (potentially) an ITAR determination and a BIS determination as to a commoditys possible Export Control Classification Number (ECCN), an exporter can move forward with reasonable certainty.

But what about that BIS classification in light of the interim final rule?  Exporters need only remember that because BIS does not have authority to issue determinations that would bind other agencies, a BIS commodity classification only identifies whether the merchandise being exported is described in the Commerce Control List (based on the ECCN).  Exporters still need to do their due diligence with other agencies to ensure export compliance.

FDA Clears First Embryonic Stem Cell Trial Using Patients to Begin

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The U.S. Food and Drug Administration (FDA) has given the “go ahead” to the worlds first authorized human trial of a treatment derived from human embryonic stem cells.  This trial will test cells developed by the University of California, Irvine and the Geron Corporation.  The cells will be used on patients with recent spinal cord injuries.

This trial was originally cleared by the FDA to begin in January of last year.  However, before the study could begin, the FDA put a hold on the Investigational New Drug (IND) application because cysts were found in some of the mice injected with the cells during pre-clinical animal trials.  Another animal study had to be conducted and the testing of cell purity had to be improved before the trial could proceed.

On July 30, Geron announced that FDA had lifted the hold on the study and that it would move forward with the worlds first clinical trial of a human embryonic stem cell (hESC)-based therapy in humans.  This Phase I trial is designed to establish the safety of GRNOPC1 in patients with spinal cord injuries.  GRONPC1 is Gerons lead hESC-based therapeutic candidate.

Embryonic stem cells have the ability to turn into any type of cell in the human body.  In this clinical trial, embryonic stem cells are turned into precursors of neural support cells called oligodendrocytes, which are injected into the spinal cord at the site of the injury.  The goal is for the injected cells to repair the insulation around nerve cells which would restore the ability of some of the nerves to carry signals.  The initial trial will focus on a very small number of clinical subjects to establish the safety of the treatment. 

Geron plans to seek FDA approval, once safety is established, to extend the study to an increased dosage of GRONPC1, enroll subjects with complete cervical injuries, and expand the trial to include patients with severe injuries to enable access to the therapy for a broader population of patients.  The biopharmaceutical company believes that there could be other potential indications for GRONPC1 such as treatment for Alzheimers Disease, Multiple Sclerosis, and Canavan Disease.

The FDA clearance of this clinical trial is a major milestone for the field of stem cell research and medicine.

For more information on Fuerst Ittlemans experience handling the FDA regulatory framework of stem cells, drugs, and biologics, please contact us at contact@fidjlaw.com.

FDA approves generic Lovenox® (enoxaparin) representing a major policy advancement for naturally-sourced generic drugs and possibly biosimilars.

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On July 23, 2010 the FDA approved the first generic enoxaparin product in a major policy advancement that will likely impact a number of other naturally sourced generic drugs and possibly biosimilars.  Enoxaparin is the generic name for Lovenox® which is manufactured by Sanofi Aventis.  The drug is a low molecular weight heparin, derived from cleavage of large heparin strands. It is an injectable anticoagulant (blood thinner) indicated for the prevention and treatment of deep vein thromboses (blood clots).  The drug was approved under an Abbreviated New Drug Application (ANDA) submitted by Sandoz Inc.  Lovenox® was originally approved in March 1993 under a New Drug Application (NDA) by Sanofi Aventis.

What makes this matter so important is enoxaparin is a naturally-derived product, more closely related to biologic drugs such as monoclonal antibodies than conventional drugs like aspirin and Lipitor.®   These products pose a number of important challenges in the generic review and approval process, unlike conventional drugs.  For example the characterization of these products is often difficult and generic versions pose important immunogenicity concerns and greater batch-to-batch variability. 

In 2003 counsel for Sanofi Aventis submitted a citizens petition to the FDA urging the agency to not approve a generic version of the drug until a number of requirements were met, in attempts to exclude competition.  Specifically, they expressed concerns with characterization of the drug and how the FDA would ensure equivalency. They requested the FDA require the generic to follow the same manufacturing practices as Sanofi Aventis or else require full-scale clinical testing to demonstrate equivalent safety and efficacy.  Moreover, Sanofi Aventis requested the FDA require the generic be a specific chemical profile, that is to contain a 1,6 anhydro ring structure at the reducing ends of between 15 percent and 25 percent of its poly(oligo)saccharide chains.

Simultaneous with the approval, on July 23, 2010 the FDA released their response to the petition.  The agency granted the petition insofar as requiring the generic to meet the chemical profile type, but denied the petition insofar as requiring the manufacturing practice to be equivalent or else require full-scale clinical investigation.  Instead the FDA established that enoxaparin has been adequately characterized and sameness of the generic to the brand would be met based on the following five criteria.   

  1. Equivalence of heparin source material and mode of depolymerization
  2. Equivalence of physiochemical properties 
  3. Equivalence in disaccharide building blocks, fragment mapping, and sequence of oligosaccharide species
  4. Equivalence in biological and biochemical assays
  5. Equivalence of in vivo pharmacodynamic profile

Essentially, by demonstrating compliance with the above standards of identity, a generic drug could prove equivalent to the brand drug without the need for full-scale clinical investigation, complete characterization, and with variances in the manufacturing process. 

The approval now means that pharmacists may substitute the generic drug for the brand, providing cost-savings to the patient and the healthcare system as a whole.  More importantly, the approval represents an important policy development by the FDA.  The FDAs establishment of criteria for sameness suggests the FDA is prepared to move on additional naturally-derived generic applications.  Furthermore, the approval suggests that the FDA will not require full-scale clinical trials for biosimilars and may approve them, even with notable differences in the manufacturing process if certain criteria are met.  Biosimilars are follow-on versions of complex naturally-derived products.  The 2010 health reform bill, the Patient Protection and Affordable Care Act, for the first time authorizes the FDA to approve biosimilar drugs in the United States under Title VII-Biologics Price Competition and Innovcation Act.  Prior to this enactment there was no real mechanism to approve biosimilar products for drugs approved under a Biologic License Application (BLA), as authorized by section 351 of the Public Health Service Act (PHS).

For information on Fuerst Ittlemans services with navigating the FDA drug approval process, please contact us at contact@fidjlaw.com.

FDA Issues Notice for Voluntary Registration for Non-Covered Retail Food Establishments and Vending Machine Operators Electing to Opt-In to Coverage of the Nutritional Disclosure Requirements of the Patient Protection and Affordable Care Act of 2010

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As we previously reported, the Patient Protection and Affordable Care Act of 2010 (“PPACA”) contains a section requiring nutritional disclosure requirements for certain retail food establishments and vending machine operators. Pursuant to section 4205 of the PPACA, restaurants and similar retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu items (“chain restaurants”) and for vending machine owners operating 20 or more vending machines (“chain vending machine operators”) are required to disclosure certain nutritional information on the foods and beverages that they sell.

On July 23, 2010, the U.S. Food and Drug Administration (FDA) issued a Federal Register Notice providing registration guidance to retail food establishments and vending machine operators who are not covered by the nutritional disclosure requirements of section 4205 but would like to elect to become subject to the requirements by registering biannually with the FDA. Retail food establishments that are not covered by section 4205 may still be subject to State and local nutritional labeling laws that are not “identical to” the Federal requirements. By voluntarily registering under section 4205, these retail food establishments will no longer be subject to State or local nutritional labeling requirements unless those requirements are identical to the Federal requirements. It is different for vending machine operators. Vending machine operators cannot be subject to State or local nutritional labeling requirements that are not identical to the Federal requirements, but may still elect to be subject to the requirements in section 4205 by registering with the FDA.

The FDA will begin accepting registrations on July 21, 2010, on a continuous basis. The registration must be renewed every other year or it will automatically expire. Restaurants, similar retail food establishments, and vending machine owners must use the FDA form at http://www.fda.gov/menulabeling  to register. For registration of restaurants or similar retail food establishments, the following information must be provided to the FDA:

  • The name, address, phone number, e-mail address, and contact information for the authorized official;
  • The name, address, and e-mail address of each restaurant or similar retail food establishment being registered, as well as the name and contact information for an official onsite, such as the owner or manager for each specific restaurant or retail food establishment;
  • All trade names the restaurant or similar retail food establishment uses;
  • Preferred mailing address for correspondence; and
  • Certification that the information is true and accurate, submitted by someone authorized to do so, and that each registered facility will be subject to the requirements of section 4205.

For the registration of vending machine operators, the following information must be provided to the FDA:

  • The name, address, phone number, e-mail address, and contact information for the vending machine operator;
  • The address of each vending machine owned or operated by the vending machine operator, and the name and contact information of the location in which each vending machine is located;
  • Preferred mailing address for correspondence; and
  • Certification that the information is true and accurate, submitted by someone authorized to do so, and that each registered facility will be subject to the requirements of section 4205.

The FDA prefers that all required registration information be sent via e-mail on the FDA form to http://menulawregistration@fda.hhs.gov.

For more information on the benefits of voluntary registration or assistance with other regulatory compliance issues for your restaurant, retail food establishment, or vending machine operations, please contact us at 305-350-5690 or contact@fidjlaw.com.