Parker Waichman LLP

FDA Closer to Placing Full-Time Staff in China

Last month, a top drug safety official told lawmakers that the US Food and Drug Administration (FDA) needs more to better track products entering the US from the burgeoning group of overseas drug manufacturers, brokers, and distributors currently doing business here. The FDA focuses on domestic companies, with about 1,200 inspections conducted annually in the […]

Last month, a top drug safety official told lawmakers that the US Food and Drug Administration (FDA) needs more to better track products entering the US from the burgeoning group of overseas <"https://www.yourlawyer.com/practice_areas/defective_drugs">drug manufacturers, brokers, and distributors currently doing business here. The FDA focuses on domestic companies, with about 1,200 inspections conducted annually in the US; however, only about 300 foreign facilities are inspected annually and, of these, about 10 percent of the firms shipping pharmaceuticals here, said Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research.

Now, in an important, new development, the FDA received approval from the US State Department to establish eight full-time, permanent positions at US diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government. This is one step in the FDA’s plans to hire and place staff in China over the next 18 months. The FDA will also be hiring a total of five local Chinese nationals to work with the new FDA staff at the US Embassy in Beijing and the US Consulates General in Shanghai and Guangzhou.

“In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters,” said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. “Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market.”

According to the FDA, this move supports its “Beyond our Borders” initiative by working to strengthen relationships with counterpart agencies globally and enhance technical cooperation with foreign regulators. The permanent overseas offices in China are being created in the hopes of allowing increased access for inspections and greater interactions with manufacturers to help ensure products shipped to the US meet US standards for safety and manufacturing quality.

Foreign inspections were especially relevant following ongoing and heightened concerns about the blood thinner heparin which has been linked to 21 deaths and adverse reactions in over 700 patients. Millions take heparin annually to avoid potentially life-threatening blood clots.

Representative Rosa DeLauro, Democrat-Connecticut, chairman of an appropriations panel responsible for FDA funding, said the agency had not inspected a Chinese factory that may be a source of problems with heparin, which is manufactured by Baxter Healthcare Corp. She called the case embarrassing, but that it helped demonstrate the FDA’s “myriad failures under the Bush administration.” Meanwhile, there’s mounting evidence supporting reports that small, homemade Chinese factories develop and supply crude heparin under filthy and unregulated conditions. In November, the Government Accountability Office found the FDA didn’t know how many foreign firms are actually subject to inspection. The agency has a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list. The agency also could not confirm how many foreign firms have never been inspected.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Parker & Waichman law firm has a Phenomenal Nurse Practitioner Joanne her bedside manner is outstanding. She is consistent on making sure I’m ok. She is a true asset to the law firm.
Wendy Medina
5 years ago
5 Star Reviews 150
I would like to thank both Benita Rollis and Shelly Davis for the wonderful job that they have done for me. They made it easy and helped through the hard times. Thank you both. Steven Lubowsky
Steven Lubowsky
a year ago
5 Star Reviews 150
They were so helpful and informative throughout the entire process. Especially Jillian. She is amazing!! I definitely recommend
Ari Ari
6 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038