Protecting the Medical Innovations that
Add Years to Our Lives, and Life to Our Years
From the moment an idea is conceived, we guide innovative scientists and companies as they incorporate, patent, license, trademark, and market their products creatively in a heavily regulated industry.
Hi, my name is Nancy Lord (that's me above, in March of 2010) and I'd like to welcome you to my website. I am both a medical doctor (physician), as well as an attorney. You have probably arrived at my website because you need assistance withpatents, trademarks, or regulatory compliance.
Is there a patent on your new product?
On July 12, 2011, US Patent No 7977378 Issued to Inventor Adel Villalobos. This patent is an excellent example of what the USPTO finds novel in nutritional supplements: a creative mechanism, fresh ingredients, a clear and brief presentation, and clinical data, even if only a few subjects.
IP Legal Review. Nancy Lord Ltd maintains an extensive data base of issued patents on hundreds of nutritional ingredients. This can save many hours of attorney time in determining if a new formula is already patented, or if a new formula is patentable. With the data base in hand, a new search can be limited to the interval since it was last reviewed avoiding the many hours spent reviewing the older patents.
Sole Inventors. In addition to the inventions Nancy has handled herself, Nancy Lord Ltd maintains a large data base of patents that have not recorded to an assignee. There is no way to search the USPTO data base for unassigned patents and this data base was compiled over many years of creating electronic files for any patents without assignees. The data base includes supplement, topical creams, cosmeceuticals, medical devices and even sports devices. If you would like to add a patented product to your portfolio, please contact me and if are an inventor, Nancy Lord Ltd will assist you in finding the right licensee.
Nancy Lord, M.D. holds active law licenses in Nevada, California, Georgia and Maryland as is a registered Patent Attorney.
Dr. Nancy Lord received her undergraduate and medical degrees from the University of Maryland her law degree from Georgetown University. She has worked for herself ever since leaving Abbott Laboratories as an Associate Director of Clinical Research before the Millennium.
Nancy Lord, MD still holds a medical license in New York where a physician is "Licensed for Life." Her firm provides clients with full-service representation as it relates to all types of innovative medical products from nutritional supplements to medical devices, and medical marijuana.
Email: click here or use nancylordltd at the google place.Please call if you do not hear from me in 24 hours.
FDA’s Stem Cell Regulations
Dr. Lord has experience in product development, patent and trademark prosecution, licensing, regulatory compliance, consumer issues, first amendment and advertising issues.
Dr. Nancy Lord received her undergraduate and medical degrees from the University of
Maryland her law degree from Georgetown University. In the early 1980's Nancy Lord was an Assistant Director at Abbott Laboratories where she wrote the New Drug Application for a benzodiazepine hypnotic, ProSom (now approved).
After leaving Abbott in 1983, she worked independently as a consultant and expert witness in pharmaceutical products' liability, pharmaceutical development, toxicology, and medical malpractice involving drugs. Lord's analyses were based upon a thorough understanding of appropriate standards in clinical trials, statistical issues, adverse reactions reporting, and concomitant medications.
Presently a sole practitioner located in rural Pahrump, Nevada, Dr. Lord's client base
includes small and medium sized corporations, manufacturers of nutritional supplements, and others offering health services. She focuses her practice on patents and trademarks, licensing, civil litigation, and regulatory compliance. Located within an hour from Las Vegas' McCarran airport, Dr. Lord often serves as local or lead counsel for plaintiffs and defendants in litigation against Nevada corporations and LLC's.
Hi, my name is Nancy Lord (that's me above, in March) and I'd like to welcome you to my website. I am both a medical doctor (physician), as well as an attorney. You have probably arrived at my website because you need assistance with patents, trademarks, or regulatory compliance.
Patents and trademarks are both areas of law in which I practice. But of course, I do have other areas of practice. Take a look around my site utilizing the navigation menu found at the top/left of this web page. My firm prepares top quality submissions and successfully litigates corporate matters for a fraction of the cost of the large big-city law firms. Based in rural Parhump, Nevada, I travel frequently to work face to face with my clients, and still pass along the substantial overhead savings to them.
I've done my best to answer some of the general questions one might have when visiting this site ... but I'm sure you may have a specific question or two that may require a more detailed answer. If so, please don't hesitate to contact me and I’ll do my best to point you in the right direction and assist you with your cause ASAP.
Be assured that you will not need to press 1 for English, “listen to our new menu so that we may assist you better,” or “set up an account” just to ask a few simple questions. Your call will be answered by a real live person, or you can leave a message and a real live person will return your call promptly. Please call if I miss an email -- new email can get tagged spam.
Email click here or use: nancylordltd at the google place. Please call if you do not hear from me in 24 hours.
© Nancy Lord Ltd, 2011
Food and Drug Law
Since 1993, Dr. Lord has defended FDA criminal cases and she became well known in the innovative medical community for her successful defense of Tierra Marketing, Inc. in 1994, charged with 15 counts of FDCA, Customs and Trademark violations. Parts of her closing argument are featured today on Gifts of Speech and her client, Rodger Sless, continues share the memories of this victory on his site. Lord later served on the team as amicus attorney in the well known case of Durk Pearson et al., v. Shalala, et al., 164 F.3d 650 (DC Cir. 1999).
Trademarks
Many of the creative names and logos visible to tourists in Pahrump, Nevada could be registered either as word marks or as designs (logos). This is important, because if they are not registered, they could be copied and used in another location. By registering your name or design, you would be entitled to treble damages under federal law if another company uses your name or design.
Dr. Lord's firm, Nancy Lord, Ltd, is recognized internationally for its work in several areas of intellectual property. The firm has professional relationships with experts in a panoply of fields who are available to work with Dr. Lord in patent prosecution in areas of medical devices, nutraceuticals, pharmaceuticals, industrial chemistry, engineering, business methods, gaming technology, and entertainment law.
Cannabis therapeutics, or "medical marijuana," is at the cusp of the same explosive industrial growth that DSHEA brought to nutritional supplements in 1994. Here is Dr. Lord's on its value in numerous serious conditions.
Nancy Lord is a Registered Patent Attorney experienced in preparing and prosecuting patent and trademark applications mostly for health and medical products. She has worked as in house counsel, part-time, for two of the nation's most successful nutritional supplement companies on Intellectual Property and Regulatory matters. But in a rare venture out of the health care field, Dr. Lord recently assisted the inventor of an elegantly simple hand beading loom in obtaining his patent:
In addition to prosecuting patents and trademarks, Dr. Lord assists inventors and corporations in developing licensing agreements with larger companies and meeting regulatory requirements.
First Amendment and Entertainment
Nancy Lord was formerly General Counsel to Sierra Times, a popular Internet news site. She has successfully represented several clients in defamation cases both in state and federal court. One of these involved statements about a competitive product on a web page. She has also negotiated contracts for the use of a celebrity's name and likeness in product sales.
Email click here or use: nancylordltd at the google place
Please call if you
do not hear from me in 24 hours.
© Nancy Lord, Ltd, 2011
NRS § 13.040 provides that "if none of the defendants reside in the State . . . the [case] may be tried in any county in which the plaintiff may designate." This means that if the Bad Guy lists his principal place of business as Illinois, we can file in Pahrump and get a hearing date within weeks, a TRO where requirements are shown, and possibly even a trial date less than a year from filing.
Proceedings happen when they are scheduled, and there are spacious and inexpensive hotels
within a few miles of the courthouse. Dr. Lord represents plaintiffs who use this statute to
avoid big city hassles and move their cases along expeditiously.
Dr. Lord offers quality and timely preparation of 510k FDA submissions for new medical
devices, and New Dietary Ingredient submissions required under the DSHEA Act for dietary ingredients that were not in use prior to October 15, 1994. She assists in designing clinical trials to substantiate structure/function and health claims, and bioavailability studies for generic drug equivalents. Formerly Associate Director of Clinical Research at Abbott Laboratories, Dr. Lord supervised the clinical trials and prepared the New Drug Application for Abbott's ProSom,
a benzodiazepine hypnotic. She is familiar with the requirements of informed consent,
Institutional Review, and other regulatory requirements for clinical trials of new medical
products.
Patents are legal instruments that create property rights in technological advances. They protect investments in time, money and other resources by inventors, venture capitalists and corporations.
When you make a scientific or other type of discovery, you may be entitled to a patent.
There are patents granted every day for a wide variety of nutritional supplements, novel compositions, and novel devices. Even an old composition may be patented as a method when utilized in a novel manner.
A creative design can also be patented, such as the design for a billboard. A design patent can be obtained for something that has only artistic value without any utility. These can be obtained even for groups of designs, such as playing cards or china. Many people find their creativity soars after retirement, and could get protection.
A patent gives an inventor or his or her assignee the right to file suit against another party who is using the invention. Once a patent issues, and sometimes even prior to issue, the patent holder or applicant can license his or her invention to others for royalties.
An application gives you the right to place a label "patent pending" on your product, and an issued patent allows you to label your product as such. This enhances the value of your discovery, and warns would-be infringers against copying.
However, there are several reasons why a patent may be barred, including even one sale of the product prior to one year before filing. For this reason, you should consult a patent attorney as soon as you feel that you might be entitled to a patent.
From her earliest years in law, Dr. Lord successfully represented clients on Federal charges including violations of the Food, Drug & Cosmetic Act and controlled substances, customs, mail and telemarketing fraud violations.
Dr. Lord was honored to represent Judy Osburn, charged with manufacture of marijuana by the federal government for the medicine she provided to the Los Angeles Cannabis Resource Center. The Court eloquently described LACRC as having had "a brief and shining moment" of transparency and rigorous compliance with Proposition 215.
Less than two months before the November 4 general election, 8 organizations that assisted patients in negotiating through the thicket of regulations of Nevada's NRS 453A "grow your own" medical marijuana statute were raided by what appeared to be a joint DEA/ IRS and Las Vegas Metro and N. Las Vegas.
As Cannabis Therapeutics become legal and accepted in numerous states, Dr. Lord looks forward to her role in assisting these therpaies to their well-deserved position in health care, with corporate, trademark, and patent filings. As long as arrests are being made, I will travel throughout Southern and Central Nevada (Beatty, Tonopah, Hawthorne, Ely, Eureka and even Elko) to defend my clients.
Dr. Lord represents clients on a variety of civil matters. Her earliest local clients included
a sharp-shooter who killed a predatory mountain lion only to have the pelt taken by the State; and the defense of a local talk show host who was sued by an personal injury lawyer.
In 2003, Dr. Lord represented the Estate of Augusta Overfield, the owner of an historic gold mine near Johnny in a dispute with Valley Electric. Valley Electric had only offered to pay them $6,000 to place a large power line over their property, but the jury awarded them $15,045, a low enough award to receive attorneys fees under NRS § 18.010. The Nevada Supreme Court agreed. Valley Electric Association vs. Augusta H. Overfield, et al, 106 P.3d 1198 (2005).
The Fifth Judicial District of Nevada, in Pahrump, offers faster and more predictable litigation than the crowded dockets of Las Vegas and Reno, and is appropriate in more cases than one might expect. Incorporation in Nevada is advantageous for many reasons, and is a popular choice for companies whose principal place of business is elsewhere.
Bar Admissions
United States Courts
State Courts
Maryland Court of Appeals
Virginia Supreme Court
D.C. Superior Court
Georgia Superior Court
Georgia Court of Appeals
Circuit Court, Leon County, Florida
Superior Court of the State Of California, County Of Madera
Superior Court of Skowhegan County, Maine
Supreme Court of Maine
Supreme Court of Nevada
Supreme Court of California
Nevada
California
U.S. Patent and Trademark Office
Georgia
Maryland
Washington, D.C. (associate)
Virginia (associate)
Dr. Lord is also a licensed (but inactive) physician and surgeon in New York.
Northern District of Georgia
Middle District of Georgia
District of New Mexico
Eastern District of Michigan
Middle District of Florida
Southern District of Florida
Middle District of Pennsylvania
District of Minnesota
Central District of California
District of Nevada
U.S. Court of Appeals, 11th Circuit
U.S. Court of Appeals, 9th Circuit
U.S. Court of Appeals, 3rd Circuit
U.S. Supreme Court
Email: click here or use nancylordltd
at the google place. Please call if you
not hear from me in 24 hours.
Email: click here or use
nancylordltd at the google place
Telephone:
775-751-3636
(Cell is on the message)
Fax:
775-473-9899
Snail:
Nancy Lord, Ltd
Attorney at Law
1970 N Leslie Rd, No 220
Pahrump, NV 89060
Licenses:
Nevada: 006697
California: 202372
USPTO: 45462
The Internet has made the world a smaller place, and we understand that not everyone is on Pacific Time. My office is usually open early enough to catch my east coast colleagues way before they go to lunch.
This office regularly handles vehicle stops and resulting cannabis arrests of persons traveling in rural Nevada -- Beatty, Tonopah, Hawthorne and even the Ely, Eureka City and Elko areas. No worries on the drive -- I love getting out into the country!
When the Vitamin people and the Hemp people and the Gun people realize that we are all on the same side, we could bring back the Republic. At least we would have a chance. Can we take it? Or do we just leave for parts unknown?
FDA attacked the Amish
On April 20, 2011, the FDA simultaneously hosted a public meeting on the|FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities|, HR 2752, and sent a|warning letter to Daniel L. Allgyer,|owner of the Rainbow Acres Farm, in Kinzers, Pa., for distributing unpasteurized (or “raw”) milk for human consumption in interstate commerce. Six days later, on April 26, 2011 the Justice Department, at the request of the U.S. Food and Drug Administration, has filed a complaint for|permanent injunction against the Amish farmer. ||Ron Paul|spoke out.
The FDA Food Safety Modernization Act |superceded Tom Harkins SB 510 and incorporated similar provisions for food facilities that were in the Dietary Supplement Safety Act (DSSA, S 3002) , passed on December 19 (Senate) and December 21 (House). The|Farm to Consumer Legal Defense Fund| worked hard to stop it.
(l) Modified Requirements for Qualified Facilities-
‘(1) QUALIFIED FACILITIES-
‘(A) IN GENERAL- A facility is a qualified facility for purposes of this subsection if the facility meets the conditions under subparagraph (B) or ( c)
‘(B) VERY SMALL BUSINESS- A facility is a qualified facility under this subparagraph--
‘(I) if the facility, including any subsidiary or affiliate of the facility, is, collectively, a very small business (as defined in the regulations promulgated under subsection (n));
Commentators including the Farm to Consumer Legal Defense Fund note that this onerous bill could apply, requiring for instance the preparation of hazard prevention plans and registration, to family farms. It is a serious threat to small farms, especially those that produce raw milk, and the FDA wasted no time in shutting down the Amish farmer. This appears to be an instrument to prevent us from protecting ourselves from upcoming food shortages with vegetable gardens, but then, I’m just afraid of big government.
HR 2751 also slipped in Sec. 113 that states that if the information in a new dietary ingredient notification "article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination." The bill is supported by the usual exaggerated concerns for public safety and requires farms and food manufacturers to register with the FDA, conform to standards for produce safety, and prepare written hazard prevention plans.
The FDA Food Safety Modernization Act incorporated, for food, some of the same onerous provisions as Dietary Supplement Safety Act (DSSA, S 3002). Several organizations report that as of March 5 Senator McCain confirmed that will no longer support his own bill, the Dietary Supplement Safety Act (DSSA, S 3002) and that he assured Senator Orrin Hatch of this.
Killing S 3002 was a huge victory for freedom. Introduced last February by Senator McCain, the Dietary Supplement Safety Act (DSSA) would have required that any dietary supplement facility register with the Secretary (of Health and Human Services, the department that includes the FDA) and provide a list of all the ingredients in all of its products.
The facility would have had to assure that it has “adequate written evidence from the preceding responsible entity in the chain of commerce that the product is registered as required.” Even non-serious adverse events (niacin flush?) would have been required to be reported to the FDA (at this time the manufacturer only needs to maintain internal records of reports) and the FDA would have had expanded recall powers and the power to issue a cease and desist order without hearing for up to 10 days. For more information, see the site of Life Extension, where I have the honor of serving as Chair of the Institutional Review Board since 2006. My personal hero, Ron Paul, through whom a short joint European television interview in 1988 led to my joining the Libertarian Party, spoke out strongly against this bad bill.
DSSA, though, is not officially dead because, while McCain has not given an official declaration of his withdrawal of support .
My colleagues in the Medical Marijuana industry have asked me why there is not more about their product on my site, and I would like to correct that problem. Medical marijuana is where the nutritional supplements industry was in 1994 before DSHEA was passed. Its healing properties, particularly in neurological conditions, are the best available for many patients. Here I am giving a speech about this in 2008, andno, I will not look like this in federal court or even on video conference. It was a picnic!
In spite of, or many because of, the powerful medicinal properties of this natural and easily producible herb, the industry remains under attack. Just last September, over a dozen small business’ by a joint federal-state task force and federal indictments were returned with alarming alacrity. Med Pot needs its own DSHEA! Ron Paul’s Health Freedom Protection Act, H.R. 2117 is a great bill, but we really need a constitutional amendment.
"Unless we put medical freedom into the Constitution, the time will come when medicine will organize itself into an undercover dictatorship. To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic.”
Dr. Benjamin Rush – Physician and Signer of the Declaration of Independence., ‘
When the Constitution was established, Benjamin Franklin stated that we had “A Republic, if you can keep it.” If you are on my site, you either agree that we have not kept it or I am under some sort of investigation and you are the case agent.
Stem cells are regulated today as Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps). §§ 21 CFR 1271 et seq, 42 USC 462 et seq, 42 USC 274 et seq. Regulation as drugs under §§ 21 USC 321, 355 require a nexus to interstate commerce that the FDA has interpreted as not being required based on a 1977 case involving contaminated turtles. Louisiana v. Mathews, 427 F. Supp. 174, 176 (E.D. La. 1977). While there is a presumed nexus to interstate commerce under the FDCA statutes, presumptions can and should be overcome.
No Court has even looked at these regulations, 21 CFR 1271 et seq, and held that they did not invade either the power of congress to legislate or the right of a physician to practice medicine freely. It has not happened.
The potential exemption of physicians who would provide stem cell transplants without the introduction of the cells into interstate commerce should be protected under 42 USC 360(g) and 21 USC 396 that state that the practice of medicine has never been intended by congress to be regulated by the FDA, but by the individual and several States. The FDA has recognized that it is not authorized by congress to interfere with medical practice. 37 Fed. Reg. 16503 (1972); 40 Fed. Reg. 15393-94 (1975)(regarding off-label use of new drugs); 44 Fed. Reg. 37435-36 (1979)(Good medical practice and patient welfare require that physicians remain free to use drugs according to their best knowledge and judgment; 48 Fed. Reg. 2673 (June 9, 1983).
During Notice and Comment for the addition of stem cells into the regulations for HCT/Ps, questions were raised as to the regulation of the practice of medicine and questionable constitutionality. These are set forth in the Federal Register Notice of 2001 concerning the final rule-making on biologics that was to go into effect in a tiered approach beginning from 75 days, two years, and four years from the rule. 66 FR 5447. Careful review of this Federal Register Notice reveals that it was an attempt to regulate neural stem cells specifically regardless of the nexus to interstate commerce required by §§ 21 USC 321, 355 and over the objections of several comments that the proposed regulations would regulate the practice of medicine. The FDA is known to legal commentators in other cases to have tread illegally on the States sole power to regulate the practice of medicine. Folkes, S., Kesslers Legacy to the FDA, 5(5) Smart Drug News (1998).
Comment 10) We received several comments on our proposed regulation of hematopoietic stem cells. One comment supported the proposal that all establishments involved with hematopoietic stem cell therapy register with FDA. Two comments asserted that the proposed regulation would jeopardize patient treatment, impede the development of new therapies, and increase the costs of treatment. One comment asserted that we lack the legal authority to regulate intrastate hematopoietic stem cell transplants. Another comment argued that clinical research involving the use of blood or bone marrow transplantation for treatment of human diseases, but not involving an investigational drug or device, should not require an investigational new drug application or investigational device exemption. This comment further requested the development of simplified procedures for evaluating those investigational devices or cellular biologic products that are more than minimally manipulated. Two comments argued that there is no need for FDA regulation as industry standards suffice and FDA requirements would be duplicative.
We believe that it is necessary to bring the regulation of hematopoietic stem cells in line with the regulation of other HCT/P's, and that we possess the legal authority to take this action. Like other HCT/P's, hematopoietic stem cells may transmit communicable diseases; thus, the basic communicable disease prevention requirements that will be contained in part 1271, including these registration and listing requirements, are as relevant to these cells as to any other HCT/P's. Intrastate activities involving hematopoietic stem cells, as well as other HCT/P's, can be regulated to prevent the interstate spread of communicable diseases under section 361 of the PHS Act. (See Louisiana v. Mathews, 427 F. Supp. 174, 176 (E.D. La. 1977).) The GAO has cited the lack of regulation of hematopoietic stem cells as a significant gap in our oversight, and urged us to proceed with implementing new regulations that would cover hematopoietic stem cells. We are now closing that gap.
66 FR 5452 [emphasis added]. The FDA disagreed that the expansion of mesenchymal cells in culture or the use of growth factors to expand umbilical cord blood stem cells are minimal manipulation. 66 FR 5457, January 20, 2001. [emphasis added]; 66 FR 5459-60 (neuronal tissue raises clinical safety and effectiveness); 66 FR 5456 (sporadic, isolated distribution between health care facilities does not make one a distributor required to comply with the regulations).
However, there is no published Federal case today in which these onerous regulations were subjected to challenge. The only case even mentioning 21 CFR 1271 et seq is a whistleblower case in which an employee informed the FDA of possible violations of the statute. Kozloski, et al, v. American Tissue Services Foundation 2007 U.S. Dist. LEXIS 72303 (USDC Minn 2007).
The regulations require only that a facility register with the FDA under the Public Health Service Act, Sec. 361 if all of a long list of criteria are met. PHS 361 is codified as 42 USCS § 264 and relates to the control of communicable diseases, the legitimate government function that the Food and Drug Administration utilized to gain control of this promising research, and save the big profits for the big drug companies.
[FN2] 21 CFR 1271.10
1271.10 Are my HCT/P's regulated solely under section 361 of the PHS Act and
the regulations in this part, and if so what must I do?
(a) An HCT/P is regulated solely under section 361 of the PHS Act and the
regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;
(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and
(4) Either:
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a) Is for autologous use;
(b) Is for allogeneic use in a first-degree or second-degree blood relative; or
(c) Is for reproductive use.
(b) If you are a domestic or foreign establishment that manufactures an
HCT/P described in paragraph (a) of this section:
(1) You must register with FDA;
(2) You must submit to FDA a list of each HCT/P manufactured; and
(3) You must comply with the other requirements contained in this part.
A facilities are also exempt is an establishment that does not recover, screen, test, process, label, package, or distribute, but only receives or stores HCT/P's solely for implantation, transplantation, infusion, or transfer within your facility. 21 CFR 1271.15(d). These facially less restrictive regulations also contain detailed requirements for labeling, 21 CFR 1271.370, and a distinct identifier code, 21 CFR 1271.290(c).
If the criteria set for in 21 CFR 1271.10 or 1271.15(d) are not met, the HCT/P products are regulated effectively as new biologics, which subjects to the same Investigational New Drug and New Drug Approval process as new drugs. The costs of these studies is nearly a billion dollars, preventing any small or even medium sized company from entering this market.
These statements, however, are not part of the finally enacted Rule, 21 CFR 1271 et seq and are the sort of expansion of legislative authority by interpretive regulations by an agency that do not require Chevron deference by the US District Court. California Dental Association, Petitioner V. Federal Trade Commission, 526 U.S. 756, 765 (1999). Moreover, an agency cannot expand the interpretation of its jurisdiction that was legislated by congress. In this case, a presumption of interstate congress has been enacted, 21 USC 379a, but that presumption can be overcome where lack of interstate commerce is apparent and there is no finding by congress that plainly intrastate transactions are to be regulated as the FDA claims in 66 FR 5447.
A regulation, promulgated by an agency, cannot control the interpretation of a statute. Although we may give deference to an agency's construction of a statute, it is the court, and not the agency, that has ultimate responsibility to construe Congress's language
These regulations appear to be open to challenge by a licensed physician who had a patient in need of stem cell treatment and a source within the same state. He would be exempt from requirement of FDA approval on his practice of medicine, 21 USC 360(g) and that the applications of that the presumption of interstate commerce was overcome under these facts.
The FDA claimed that did not intend to regulate the practice of medicine when it added stem cells to the list of biologics in 2001, 66 FR 1542, January 20, 2001; 21 CFR 1271.3 (2002) did not include stem cells in the listing of biologics; 21 CFR 1271.3 (2004) included stem cells but mandates only licensing of the manufacturing facility and its products, but 21 CFR 1271.440 (November 2005) allows the FDA to take possession of and/or destroy the a HCT/P that is produced or marketed in violation of the rules.
As an analogy, in 2005, congress enacted 42 USCS § 274 that created a therapeutic outcomes database. The Secretary would not need to establish and maintain a scientific database if stem cell transplanting physicians were to submit INDs on their work. There was never, and is still no requirement that the organizer of the shipment of a human fetus, a vascularized human organ, to a licensed facility for the harvesting and transplantation of stem cells is required to obtain IND approval from the FDA.
The FDA does not have the legislative authority to regulate even a new drug unless it is introduced into commerce. §§ 21 USC 331 (a); 21 USC 355 (a). No approval of a new drug application, for which an IND is a preliminary, is required unless a drug is to be introduced into interstate commerce. Id. Even where a miscarried fetus were to move in interstate commerce, it is more akin to a vascularized organ for transplantation and no more regulated by the FDA than a human liver or kidney. Were fetal sources of stem cells, or the cells themselves, regulated as organs, it would be illegal to sell them.
(a) Prohibition. It shall be unlawful for any person to knowingly acquire,
receive, or otherwise transfer any human organ for valuable consideration for
use in human transplantation if the transfer affects interstate commerce. The
preceding sentence does not apply with respect to human organ paired donation.
(b) Penalties. Any person who violates subsection (a) shall be fined not more
than $ 50,000 or imprisoned not more than five years, or both.
42 USCS 274e. Prohibition of organ purchases
The prohibition on sales, should stem cells or their sources be regulated as organs would eliminate a potential windfall to biotechnology and pharmaceutical companies and could drive the price of these treatments beyond what the typical American can afford. The organ data-base program is functioning effectively in spite of the difficult statistical chance of obtaining a match for a child in need, for instance, of a kidney.
In the case of neural stem cells, no match is required. It appears to be preferable that the cells be donated as are organs, and that the corporations and physicians who perform the transplants earn their income by charging for the time and skill in effectuating that, not for the cells themselves.
