Practice of Medicine or Drug Biologic Product—Regenerative Sciences, LLC

“Practice of Medicine” or FDA Authority to Regulate

The Food and Drug Administration and the Authority to Regulate

Regenerative Sciences, LLC vigorously defended its position that FDA could not regulate the practice of medicine in its Regenexx™ treatment or Regenexx-C™ cultured treatment which uses Mesenchymal adult stem cells (MSCs) that originate primarily from bone marrow. The company promotes the Regenexx™ treatment as a “non-surgical” treatment option for joint or bone pain in the hip, knee, shoulder, back or ankle as well as non-union fractures. The dispute with FDA has been ongoing since at least 2008 when FDA sent correspondence to Regenerative Sciences depicting the cell treatment as a drug or biologic. FDA conducted an inspection and found violations of current Good Manufacturing Practices (cGMPs). The United States Court of Appeals for the District of Columbia Circuit upheld the District Court and the United States Food and Drug Administration’s (FDA’s) argument that Regenerative Sciences “Cultured Regenexx Procedure” was a biological drug subject to FDA approval through the biologics licensing application (BLA) process. The court of appeals upheld the permanent injunction against the use of the biological drug without FDA approval. The issue focused on the practice of medicine versus the regulation by the United States Food and Drug Administration. This distinction has far reaching ramifications.

Issue the Court of Appeals Addressed

In the civil enforcement action, the court of appeals had to decide “whether the appellants—three individuals and a related corporate entity—violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient’s stem cells and the antibiotic doxycycline.” The court of appeals determined that FDA had the authority to regulate the product and affirmed the district court’s judgment and the permanent injunction it entered against appellants.

What Regenerative Sciences, LLC Argued

Regenerative Sciences, LLC (Regenerative Sciences) alleged several arguments that their product did not fall within FDA regulatory authority; however, the court rejected all of the arguments. For example, Regenerative argued that the Federal Food, Drug, and Cosmetic Act (FDCA) did not apply because the product was a procedure overseen by state “practice of medicine”. Another argument advanced by Regenerative Sciences was that the product was exempt from FDA approval because it was a compounded product and further it was a minimally manipulated product. As mentioned, the court of appeals rejected all of the arguments advanced by Regenerative Sciences.

Looking Ahead

This was a long awaited decision. The future is uncertain in terms of how a court will rule about novel therapies such as the issue in this case. However, no doubt as more technological advances occur, FDA will again be challenged as to the agency’s authority to regulate such products and or procedures.The link to the full case is as follows:

USA v Regenerative Sciences

Top 5 Highlights of FDA Accomplishments in 2013—Snapshot Year in Review: Why the United States Needs a Food and Drug Administration.

Does the United States Needs a Food and Drug Administration? Year in Review—Top 5 Highlights of FDA Accomplishments in 2013

Does the United States even need a Food and Drug Administration (FDA)? The role and mission of FDA has been debated for years. The FDA role ranges from that of a regulator, watchdog and facilitator. Commentary ranges from overbearing federal regulation to lack of public protection. Yet, based on these selected accomplishments, FDA provides an important function in keeping with the mission of the Food, Drug and Cosmetic Act and the numerous amendments. Although the FDA has across the board accomplishments, the following are standouts and all involve safety—Food Safety Modernization, Drug Quality and Security, Tobacco Products, Antibiotic-Antimicrobials Use in Food Producing Animals and Dietary Supplement Enforcement.

DRUG SAFETY—DRUG QUALITY and SECURITY ACT

This necessary and milestone legislation (H.R. 3204) enacted towards the end of 2013, addresses federal regulatory authority over pharmacy compounding. Unfortunately, this legislation was enacted in response to the unnecessary deaths associated with large scale compounding. Additionally, this law contains “track and trace” provisions throughout the drug supply chain.

DIETARY SUPPLEMENT OVERSIGHT

Dimethylamylamine DMAA—Muscle Building and Performance Enhancement

Dimethylamylamine commonly known as (DMAA) provides an excellent illustration example of issues related to post-market enforcement. DMAA, a stimulant is used in supplements, promotes weight loss, muscle building and performance enhancement. DMAA, a stimulant is used in supplements, promotes weight loss, muscle building and performance enhancement. According to FDA, medical issues associated with DMAA include elevated blood pressure, potential cardiovascular problems such as heart attack, shortness of breath and tightening of the chest.

The following link contains the FDA warning letters. http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/ucm346576.htm

The following link contains the response letter from FDA to USPlabs. http://1.usa.gov/1lcJC77

ANTIMICROBIAL RESISTENCE

At the end of 2013, FDA issued a guidance and proposed rule about a phase out of antimicrobial drugs in food animals for food production purposes. According to FDA, the agency issued voluntary guidance that promotes the judicious use of antibiotics in food animal production is preferable because of resource limitations; that is, according to FDA, the agency would use fewer resources compared to withdrawing the animal drugs on an individual basis

VETERINARY ACTION—ANTIMICROBIAL VOLUNTARY PHASE OUT

Final Guidance and Proposed Rulemaking Rx Status

http://1.usa.gov/1bHsi92

TOBACCO PRODUCTS REGULATION

Tobacco Product Marketing Orders

http://1.usa.gov/1kCu7aV

Tobacco products are regulated so differently than other FDA regulated products due to the fact they are: harmful yet still extensively used consumer products; and responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death. A company who desires to market a new tobacco product has the following options available.

There were 17 SE orders, 13, NSE orders and 162 Report Withdrawals from pre-June 2013-December. http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm

MODERNIZING FOOD SAFETY

Did you know that much of the food that Americans consume originate from countries outside of the United States? The Food Safety Modernization Act (FSMA), signed into law back in January 2011, addresses imported food as well as food produced in the United States. Major accomplishments include a final rule and five proposed rules.

Final Rule Administrative Detention of Food   Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption which amended the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. A guidance was issued as well titled: Guidance For Industry on Administrative Detention  was issued on March 7, 2013 FDA released revised guidance on administrative detention entitled “Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide.”

5 Proposed Food Safety Rules: Preventive Controls; Produce Safety; Foreign Supplier Verification, Third Party Accreditation and Intentional Adulteration Mitigation Strategies.

1. Proposed Rule: Preventive Controls for Human Food — The proposed rule issued January 2013 would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls.

http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-0001

2. Proposed Rule: Produce Safety— The proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0921-0001

3. Proposed Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals— On July 26, 2013, FDA issued proposed regulations that would greatly strengthen the oversight of foods imported for U.S. consumers. http://1.usa.gov/1jEeD8l

4. Proposed Rule: Third Party Accreditation of Auditors or “Certification Bodies”— On July 26, 2013, the FDA published for public comment its proposed rule to establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361903.htm

5. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

This proposed rule would require the food businesses in the United States and abroad to take measures to prevent facilities from being the target of intentional attempts to contaminate the food supply. http://1.usa.gov/1fVCv2p

RECOMMENDATIONS

Despite the federal government shutdown, FDA did have major accomplishments as the above examples illustrate. They illustrate the necessity for “an FDA”. Hopefully though the proposed rules will be finalized shortly and hopefully Congress will revisit FDA regulatory authority for some products such as dietary supplements where FDA can only legally exercise post-enforcement. Stay tuned for more about the role of FDA and for more food and drug law updates in 2014.

Curious About Veterinary Pharmacy Compounding—Who Really has Regulatory Oversight

Veterinary Pharmacy Compounding and Regulatory Oversight

The news about pharmacy compounding has mainly focused on humans. Just recently, the 60 Minutes television program interviewed FDA Commissioner Margaret Hamburg about pharmacy compounding. Pharmacy compounding usually involves a small quantity of custom made prescriptions. However, this has changed over the years to what some term large scale production. Unfortunately, this matter come to the forefront as a result of the deaths associated with compounded products produced by the New England Pharmacy Compounding Center. I agree with Dr. Hamburg that clear guidance is necessary as well as federal regulatory oversight. To that end, Congressional action remains paramount. Federal regulatory oversight with clear guidance for the industry is necessary for human as well as veterinary use. The same rules that apply to compounded products for humans should apply to animals, both food producing and nonfood producing and those rules should be federal oversight. This will provide uniformity and provide the industry with a uniform standard.

Veterinary Use of Pharmacy Compounding Products

However, what about animals and the use of compounded pharmacy products? Do the same rules apply? If so, which rules—federal or state? As indicated on the recent 60 Minutes television program, pharmacy compounding has ballooned from a “Mom and Pop” process into a billion dollar industry. Does the regulation of pharmacy compounding even apply to food producing animals? States are the prime regulator of pharmacy compounding yet should there be federal regulatory oversight?

Congress Needs to Step to the Plate

The landscape has changed in the pharmacy compounding arena from that of compounding for an individual patient to that of large scale production. This is analogous to the changed landscape of health care and the practice of medicine. The images of “Norman Rockwell’s Going to the Doctor” are no longer. These issues remain in flux with regulation primarily under state jurisdiction until Congress enacts legislation to provide clear guidance to both the United States Food and Drug Administration and industry.

Pharmacy Compounded Products in the Veterinary Arena—Interesting Case Yet No Guidance

Taking this issue one step further—should federal regulatory oversight of pharmacy compounded products for non-food producing animals apply? The answer is unclear at this point. Interesting, this issue was addressed back in 2011 in the case of United States v. Franck’s Lab. Inc. No. 5:10–cv–147–Oc–32TBS (Sept. 12, 2011), a case which concerned pharmacy compounding for non-food producing animals. Several polo horses died as a result of use of compounded products. FDA instituted a legal action for an injunction against Franck’s Lab. Inc. and deemed the activity manufacturing and hence being subject to FDA oversight. In Franck’s Lab., the district court wrote an extensive opinion about the application of federal oversight to pharmacy compounding pertaining to non-food producing animals. The district court judge denied the injunctive relief sought by FDA and ruled that FDA had no authority to regulate in this arena mainly because this type of regulation was historically regulated under state not federal authority. Predictably, the FDA appealed. Subsequently, Wells Pharmacy Network, LLC acquired Franck’s and Franck’s no longer engages in such compounding. A Joint Motion by the government and by Wells Pharmacy Network, LLC to Vacate the District Court’s Judgment and Dismiss the Complaint by the federal government and Appeal by the government as Moot was granted on October 18, 2012. However, fast forward to 2013 and the answers as to food- producing and non-food producing animals are still murky.