Agreement Between FDA and China

FDA - SFDA

Agreement between
the Department of Health and Human Services
of the United States of America
and the State Food and Drug Administration
of the People's Republic of China on
the Safety of Drugs and Medical Devices

The Department of Health and Human Services (“HHS”) of the United States of America ("United States") and the State Food and Drug Administration ("SFDA") of the People’s Republic of China ("China") (hereinafter referred to together as "the Parties"):

Understanding the mutual benefits of protecting the public health through improved cooperation between the Parties with regard to monitoring and regulating the safety of drugs and medical devices;

Desiring to work together to better ensure the safety and quality of Drugs, Excipients, and Medical Devices; and

Recognizing that such cooperation can improve the health of the citizens of both the United States and China and enhance confidence in the regulation of Drugs, Excipients, and Medical Devices in both countries;

Have agreed as follows:

Article I    Purpose

The purpose of this Agreement is to establish methods of cooperation between the Parties that will provide the Food and Drug Administration within HHS (“HHS/FDA”) with additional information about products exported from the customs territory of China to the United States, provide SFDA with increased sharing of information about products exported from the United States to China, and encourage further regulatory cooperation between the Parties regarding Drug and Medical Device regulation.

Article II    General Principles

1. The Parties shall engage in regulatory cooperation regarding the export of Drugs, Excipients, and Medical Devices from the customs territory of China to the United States and Drugs, Excipients, and Medical Devices produced in the United States and exported to the customs territory of China as set out in Article VI and as further defined in Work Plans to be agreed upon by the Parties.
2. The Parties shall engage in information-sharing to improve their mutual understanding of, and to gain greater confidence in, each Party’s regulatory system as set out in Article V and as further defined in Work Plans to be agreed upon by  the Parties.  As specified in Article V, each Party shall share relevant information with the other Party, including on relevant laws, regulations, areas of jurisdiction, and public health and safety.
3. The Parties shall engage in regulatory cooperation regarding improving the authenticity, quality, safety, and effectiveness of Drugs, Excipients, and Medical Devices as set out in Articles IV and VI and as further defined in Work Plans to be agreed upon by the Parties. 

The Parties shall commit to annual meetings between senior Agency leaders to discuss and evaluate progress under this Agreement, among other things.

For purposes of this Agreement the following definitions shall apply:

1. "API" or "Active Pharmaceutical Ingredient" means any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product.  Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.  
2. "Counterfeit Drugs and Medical Devices" means a product that is deliberately and fraudulently mislabeled with respect to identity and/or source.  Counterfeiting can apply to branded and generic products and may include products with correct ingredients, with wrong ingredients, without active ingredients, with incorrect quantity of active ingredient, or with fake packaging.
3. "Designated Drugs and Designated Medical Devices" means a Drug (including APIs) and Excipients or Medical Device, respectively, designated for inclusion in each phase of implementation, based on criteria established in Article IV. A.
4. "Drug" means any material commonly used for human pharmaceutical use.  The term includes the following materials:
   1. Finished-dosage forms (including both over-the-counter ("OTC") and prescription drugs);
   2. Drug substance, or active pharmaceutical ingredients ("APIs");
   3. Biologic drugs (e.g., vaccines and monoclonal antibodies); and
   4. Products taken by mouth intended to supplement the diet that:
      1. bear or  contain one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use in humans to supplement the diet by increasing the total dietary intake; ora concentrate, metabolite, constituent, extract or combination of any of the above; and
      2. meet any one of the following characteristics:
             - are not clearly labeled as dietary supplements; or
             - contain claims to diagnose, cure, mitigate, treat, or prevent disease; or
             - contain substances that are regulated by HHS/FDA as APIs.

To read the rest of the agreement, click here.

K-V prompts FDA Investigation into Compounding Pharmacies--Makena--API Source from China

K-V prompts FDA Investigation into Compounding Pharmacies--Makena--API Source from China

To read article, click here 

Medisca, Inc. and Signature Compounding Pharmacy: Overview of Criminal Case

Here is another example of a compounding pharmacy, Signature Compounding Pharmacy, charged in a criminal case.  Signature was located in Orlando, Florida but the criminal case was brought in Albany, New York.  The Florida Department of Health filed administrative complaints against the pharmacy for improper distribution of human growth hormone but never pursued the charges.  Signature closed down after the indictment.  A Plattsburgh pharmaceutical company, Medisca Inc., and its president, a Canadian citizen, both pleaded guilty to misdemeanor federal drug charges for mislabeling more than $1 million worth of human growth hormone that was imported from China and distributed to pharmacies around the country.  Signature Compounding Pharmacy was among the customers of  Medisca, Inc, which had corporate offices in St. Laurent, Quebec.  This case has led to 17 convictions. The remaining case is against Naomi Loomis; her husband, Robert "Stan" Loomis; his brother, Kenneth Michael Loomis; Kirk Calvert; and Anthony Palladino.

Soares defends steroids case
Albany prosecutor cites factual errors in federal ruling; rejects bias claim
By BRENDAN J. LYONS Senior writer
Published 05:00 a.m., Monday, September 13, 2010

ALBANY -- Prosecutors have asked an Albany judge to forge ahead with a criminal trial for five Florida pharmacy operators accused of being at the center of an alleged illegal steroids business. It's a part of a case that drew national interest in 2007, but that has since brought attacks on the Albany County district attorney's office.
The remaining criminal case, which targets the pharmacist-owners of Orlando's former Signature Compounding Pharmacy, has languished for three years following an interstate law enforcement raid in February 2007 -- spearheaded by Albany County prosecutors -- that exposed illicit steroid use by professional athletes and others.

More than 15 people, including doctors and business owners, pleaded guilty to related drug charges in a case that exposed systemic abuse of prescription drug laws. But the case against the pharmacists and their managers, who were also targets of a related federal criminal investigation, has thrust a spotlight on District Attorney David Soares' decision to indict operators of a faraway company that did a small percentage of its multi-million-dollar business in New York state and Albany County.
Two years ago an Albany County judge threw out the first indictment against the pharmacy's operators, citing prosecutorial missteps in the grand jury proceedings. A month later, the pharmacists fought back with a federal civil rights lawsuit in Florida seeking millions of dollars in damages for false arrest and malicious prosecution. They sued Soares, an assistant district attorney, the Orlando Police Department and other law enforcement officials.
But their criminal case in New York was not over. Earlier this year a state appellate court reversed a portion of the county judge's dismissal order that barred prosecutors from bringing a new indictment, which they did in June.
Last month defense attorneys for the five Signature defendants asked the same judge who dismissed the first case, County Judge Stephen W. Herrick, to do it again. This time, they claimed similar grand jury problems and also pointed repeatedly to a scathing analysis of the investigation last June by a federal judge in Florida, whose ruling has the civil rights lawsuit on course for a jury trial in Florida
"Soares not only participated in, but directed (assistant District Attorney Christopher) Baynes and others to violate plaintiffs' Fourth Amendment right to be free from unlawful arrests," wrote the federal judge, Gregory A. Presnell. "Rather than wait for any documentary evidence that plaintiffs had committed a crime in New York and comply with the very limited requirements of federal and state extradition statutes, Soares decided to orchestrate Plaintiffs' arrests without valid New York warrants and, in the process, garner significant media attention."
Last week, Christopher D. Horn, special counsel to the Albany County district attorney, filed a 34-page motion that seeks to uphold the latest 33-count indictment. It also accuses the federal judge of making numerous factual errors. Horn's written statement marks the first detailed response to Presnell's searing criticism of the Albany district attorney's investigation.
Lawyers in the criminal case are subject to a gag order and were unable to comment for this report.

Prosecutors and investigators have previously characterized Signature pharmacy as a prescription mill that manufactured many of its own drugs, including steroids, that were marketed to people through "wellness clinics" that did a large volume of business through the Internet. Several people convicted in the case admitted they set up the wellness clinics that funneled prescriptions to Signature, which mailed drugs to people around the country. Some of the clinic operators said they paid doctors to write prescriptions for people who were never evaluated in person, and who had no legitimate medical need for the controlled substances, including steroids and human growth hormone.
The case, especially the fallout of its exposure of illicit drug use by athletes, shook up the pro sports world. It also was cited by former Sen. George L. Mitchell in his 2007 report on illegal steroid use in Major League Baseball.
While Signature's defense team has characterized their clients as law-abiding pharmacists who were victims of a zealous prosecutor, others convicted of dealing with them have cast doubt on that assertion.
Last year in Rhode Island, Orlando businessman Victor Martin Effron pleaded guilty to federal charges related to the illegal importation of human growth hormone from China. Federal authorities said the product was being sold to Signature pharmacy, which had contracted Effron to smuggle the drug into Florida, and marketed as approved for use by the Food and Drug Administration.
Orlando police, who were an integral part of the Signature case, asked Albany's prosecutors four years ago to join their investigation after building a criminal case from wiretaps, cooperating witnesses and evidence collected from trash bins outside Signature's pharmacy. They solicited the interest of Soares, according to court records, because the company dispensed prescriptions in New York, which has some of the strictest prescription drug laws in the nation.
Still, defense attorneys have countered that Soares, known from his position as district attorney for the state capital, only became involved in the case to thrust himself into a national spotlight. They said the new charges should be dismissed, or a special prosecutor appointed, because Soares' office has a conflict due to the related federal civil rights lawsuit that has gained traction in Orlando.
Horn, who also handles appeals for the office, countered last week that appointing a special prosecutor would set a precedent for criminal defendants to disqualify prosecutors from pursuing cases by suing them, then claiming there is a conflict.
"The defendants had been being prosecuted for the same criminal conduct for well over a year prior to the filing of their federal civil lawsuit," Horn wrote in the motion to Herrick. "Now the defendants argue that the filing of a fifth indictment is evidence of bias born of the 'conflict' which the defendants themselves manufactured. They are in no different position than they were before they filed their lawsuit. They were being prosecuted then and they are being prosecuted now."
The defendants, three of whom are licensed pharmacists in the state of Florida, are: Naomi Loomis, 37, her husband, Robert "Stan" Loomis, 59; Kenneth Michael Loomis, 62, who is Robert's brother; former business manager Kirk Calvert, 40; and former business manager Tony Palladino, 34.
Horn's motion also attacks key sections of the federal court order, and notes that days after Presnell ordered the civil case to proceed, the judge abruptly issued a corrective order dismissing the claim against a former state Health Department investigator, Mark Haskins, who had played a key role in the Signature investigation.

To read the remainder of this article, click here.
To read more about this case, click here, here, here, and here.