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.

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Fuerst Ittleman Assists Clients and Earns a “Thank You”

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Bio-Nucleonics, Inc., a leading Florida company specializing in radiopharmaceuticals, medical devices and imaging agents, gave a hearty “Thanks” to Fuerst Ittleman in its most recent issue of BioBulletin, the companys newsletter.

Fuerst Ittleman recently assisted Bio-Nucleonics with gaining FDA approval for the companys new Doral, Florida product manufacturing facility. The FDAs approval certifies that Bio-Nucleonics uses “current Good Manufacturing Practice” (cGMP) in all its production at this state-of-the art facility.

The FDA also gave approval to Bio-Nucleonics for its proposed release criteria and timeframes for specific lot release tests to be completed prior to shipment of finished drug products. The importance of this ruling is that no material is lost to radioactive decay and each dose can be shipped immediately to the customer.

FHI assisted Bio-Nucleonics with both of these efforts. We found it such a pleasure to work with clients who were as knowledgeable, dedicated, and thorough as the team at Bio-Nucleonics, and were glad that they liked working with us, too.

Let Fuerst Ittleman help guide your company to its next success. For more information, contact us today at 305.350.5690 or contact@fidjlaw.com

IRS Considers Oversight of Tax Return Preparers

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On June 4, 2009, the IRS announced plans for a comprehensive program aimed at tax return preparers.  According to IRS Commissioner Doug Shulman, the recommendations of the Service will “better leverage the tax return preparer community with the twin goals of increasing taxpayer compliance and ensuring uniform and high ethical standards of conduct for tax preparers.”

 

Recognizing that “tax return preparers help Americans with one of their biggest financial transactions each year,” Mr. Shulman announced that the IRS “must ensure that all preparers are ethical, provide good service and are qualified.”  Certainly, the need for such recommendations from the IRS is great.  A recent study by the Treasury Inspector General for Tax Administration found that 61% of tax returns completed by unlicensed paid preparers contained errors.

 

Moreover, the tax return preparation industry is enormous and getting bigger.  According to IRS estimates, over 80% of taxpayers either hire a tax preparer or use tax-preparation software.  And while enrolled agents, certified public accountants and licensed tax attorneys must register with the IRS and meet minimum training requirements, other, unregulated tax return preparers can work on tax returns without such safeguards.  “Right now, there is no clear national standard regulation of paid tax-return preparers,” said Mr. Shulman.

 

Although still in formation, the IRS reports that the potential recommendations could focus on:

  • a new model for the regulation of tax return preparers
  • service and outreach for return preparers
  • education and training of return preparers
  • enforcement related to return preparer misconduct.

The process will begin with information gathering from agents, lawyers and accountants as well as unlicensed tax preparers and software vendors.  The agency reported that it will also seek the input of consumer groups and taxpayers, and will open “a transparent and open dialogue about the issues,” according to Mr. Shulman.  “At this early and critical stage of the process, we need to hear from the broadest possible range of stakeholders.”

 

Fuerst Ittleman will continue to monitor this evolving effort by the IRS, both for how it will affect our clients and friends, but also to remain actively involved in developing the recommendations with the agency.

 

For more information, contact Fuerst Ittleman today at 305.350.5690 or contact@fidjlaw.com.

Food Safety Legislation Update

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The House Energy and Commerce Committee convened to discuss draft legislation that would broadly affect regulation of food production, importation, and manufacturing inside and outside of the U.S.  Newly confirmed FDA Commissioner Margaret Hamburg testified before the committee on The Food Safety Enhancement Act of 2009 (FSEA).

 

FSEAs major initiatives are:

  • Registration fees for domestic and foreign producers as well as importers
  • Creation of an identification system for businesses in the food supply chain
  • Risk-based frequency levels of inspection
  • Increasing FDAs subpoena power
  • Two tier approach to recalls: voluntary and mandatory

Democratic Party proponents, led by Representative Dingell of Michigan, emphasized the “dire situation” of food safety and characterized the legislation as a means of recreating the FDA with new and stronger enforcement and financing tools.  Opponents largely criticized the passing of costs to consumers, regulation that does not guarantee results, and also chided the hearing on draft legislation, rather than a finalized text.  Another recurring critique was the broad discretion given to make mandatory recalls.  Some committee members took exception to the Commissioners admission that senior officials, not only the Commissioner, might be given the power to issue mandatory recalls.

 

Commissioner Hamburg unequivocally supported the legislation, saying that it would base food safety monitoring on prevention.  She also agreed with the legislations legal empowerment of the agency as well as its requirement that user fees be generated by the food industry.

Scientific Developments in Induced Pluripotent Stem Cells

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This week has seen the publication of two reports of groundbreaking results in the field of stem cell research.

 

Scientists at San Diego Californias Salk Institute for Biological Studies have published a report in Nature describing the creation of induced pluripotent stem (iPS) cells.  Dr. Juan Carlos Izpisua Belmontes team applied gene therapy techniques to correct defective cells from patients afflicted with Fanconi anemia.  The team reports that the created iPS cells are indistinguishable from human embryonic stem cells.  Although the research has not yet been used in humans, the iPS cells create hope that such correction might be done to the diseased cells of Fanconi anemia patients. Upon correction, the cells could be reintroduced to the patient, without risk of rejection, to rid the patient of the affliction.

 

Chinese Scientists at the Shanghai Institute of Biochemistry and Cell Biology have created iPS cells adaptable to the human body from the tissue of pigs.  Similarly, the iPS cells resulting from the Chinese teams procedure are identical to embryonic stem cells.  Researchers believe that these results accomplish a necessary step towards the use of pigs to generate human-compatible organs.  Some also think this research could enable human-like simulations of human diseases and thus a platform for drug and biologic testing which would be as much like a human clinical trial as possible.

 

View the reports here:
http://www.nature.com/nature/journal/vaop/ncurrent/pdf/nature08129.pdf

http://jmcb.oxfordjournals.org/cgi/content/abstract/mjp003

 

Foreign Bank Accounts and the IRS

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Original Article: Mitchell S. Fuerst: Foreign Bank Accounts and the IRS [pdf]

The IRS Targets Taxpayers Hiding Assets in Offshore Bank Accounts

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Voluntary Disclosure Guidelines Give Taxpayers Until September 23rd to Reveal Offshore Assets

According to a statement on Offshore Income given by IRS Commissioner Doug Shulman, U.S. Taxpayers and entities that are currently hiding assets in offshore accounts have a limited voluntary disclosure period until September 23rd , of 2009 to reveal those accounts before the IRS takes the offensive. After the voluntary disclosure period, the IRS plans to aggressively pursue both civil and criminal penalties for taxpayers that fail to take advantage of the voluntary disclosure initiative. Furthermore, the IRS revealed that they are actively tracking entities and individuals attempting to clean up their act through “quiet disclosures,” the practice of Taxpayers declaring a prior increase of income through amended tax returns.

The IRS stated, “Those taxpayers making ‘quiet’ disclosures should be aware of the risk of being examined and potentially criminally prosecuted for all applicable years.”

It seems that the IRS has decided to take an aggressive position here. In a statement given by the IRS regarding the penalties for the 52,000 holders of undeclared UBS bank accounts, the IRS only mentioned a “reduction of penalties,” for those that took advantage of the voluntary disclosure practice.

Under the new IRS guidance, the quiet disclosure practice is no longer a safe measure to make amends to the IRS. President Obama recently mentioned the appointment of congressional authority to hire an additional 800 IRS agents assigned to track down and pursue illegal tax evasion and the use of undeclared offshore accounts. Though it is legal for Americans to have offshore accounts, the U.S. Treasury Department requires any account containing more than $10,000 to report the existence of the account, and taxes paid on the income as well.