Urgent: Congress Needs to Mandate Our Meds be Made in the US!

This is necessary to protect the public health, the public safety, and the security of all of our residents, our visitors, and our military.

Thank you to NBC News for bringing to the forefront the seriousness of this issue for the protection of our health and national security: “Growing concerns over China’s control of American drug supply.”

Also, thanks to Rosemary Gibson for her congressional testimony. She is the “senior advisor at The Hastings Center, the author of “China Rx: Exposing the Risks of America’s Dependence on China for Medicine.”

“The U.S. Has Lost Virtually All of Its Industrial Base to Make Generic Antibiotics: The nation’s health security is in jeopardy. The U.S. can no longer make penicillin. The last U.S. penicillin fermentation plant closed in 2004. Industry data reveal that Chinese companies formed a cartel, colluded to sell product on the global market at below market price, and drove all U.S. European, and Indian producers out of business. Once they gained dominant global market share, prices increased.”

If this does not scare Congress and other decision makers into action, I don’t know what will.

A decade or more ago, a national news story reported that the FDA did not have enough inspectors in the United States let alone abroad. At that time, the issue was drugs that were manufactured in places such as Europe. This was at a time when many seniors and others were traveling regularly to Canada to get prescription drugs. Other patients were making “mail order” prescriptions from Canada, and the U.S. Government was warning about the safety of those mail order prescriptions.

In 2012, I wrote a letter to my Congressman who at the time was Henry Waxman. I was concerned about the way prescription drugs were being dispensed, and that it was the insurance companies that were determining what drugs a patient could have according to their formulary. At that time, I was also concerned about the importation of medications from Rambaxy Pharmaceuticals in India. See:

“FDA Statement on the Ranbaxy Atorvastatin Recall.”

This is a summary of what I asked Congressman Waxman to do in 2012:

“Congressman Waxman, would you consider making the following recommendations to the FDA to create confidence in generic drugs and to support the American economy:

Create a “FDA Preferred Generic” designation for any generic drug manufacturer that agrees to:

To purchase its chemicals from U.S. chemical manufacturers that are sited within the 50 United States and its territories;

To manufacture the generic drugs for U.S. distribution within the 50 United States and its territories;

Grade all drug manufacturing companies in the United States with a report card like the one used by the Los Angeles County Department of Health for restaurants.

If a generic manufacturer meets all of these criteria (above) with an A grade of its facilities, it could earn the “FDA Preferred Generic Designation.”

As I look at what I wrote to Congressmember Waxman, the importance of that request holds even truer today. Today we are being told that 80% of our drug supply is controlled by China. But it is not just the drugs that are a problem – it is the precursor chemicals as well. About 80% of the precursor chemicals are being imported from China, India, and other foreign governments.

My concern now is, and always has been, about quality control. Many politicians and advocacy groups talk about the need for lower prescription drug prices – but at what cost? Are they aware of the quality control problems that many Americans are having with both their prescriptions and over-the-counter (OTC) medications?

Last year, I wrote to another elected official who I hoped would sponsor legislation at the California level regarding our prescription drugs and imports. I sent him the link to this article from Consumer Reports in 2014: “Are generic drugs like Apotex medication made in India safe?”

Here is an excerpt from the article:

“Why has the number of FDA sanctions against companies with drug plants in India increased?

One of the main reasons is that inspectors from the U.S. and India have ramped up efforts to make sure that plants in India making the drugs exported to the U.S. adhere to the strict manufacturing standards and regulations required by the FDA. With more and more companies such as Apotex making drugs in other countries, FDA inspectors were spread far too thin. In 2012, Congress passed the FDA Safety and Innovation Act, which among other things, requires the agency to inspect foreign facilities that make drugs sold in the U.S. as frequently as it does domestic plants. Last year, the Indian government approved adding seven new FDA drug investigators, to bring the total up to 19 U.S. staff members working in India.

A spokesman for the FDA confirmed in an e-mail that the agency is stepping up its efforts abroad, including in India. “What we’ve found is that most Indian firms understand good manufacturing practices and use them, but we’ve seen problems with a few companies," the representative said. "That’s why we‘ve chosen to make quality one of our highest priorities this year.” The agency also says that import bans affect only a fraction of the drugs made in India for the U.S. market.”

One of my concerns for a number of years is this: we have to label the Country of Origin for food consumed in the United States, so why are our prescription and OTC drugs not required to be labeled for their country of origin?

Over the past decade or so, if a BRAND name drug was ordered by my physician, I would have to ask them for insurance purposes to write: “Dispense as Written” or DSW2. If my physician did not write this on the order, the pharmacy or their staff could automatically order the generic form of the medication even if my physician understood why I wanted BRAND only. Often, I would find that the BRAND was made in Canada or Europe which I felt was preferable to imports from China or India due to ongoing recalls for drugs manufactured in the latter two countries.

If I found that the drug was unaffordable for the BRAND, and there was a generic made in the United States, I would request that prescription to reference a specific generic name and manufacturer. But what I have found in recent years is that:

A generic drug that was once made in the United States may suddenly be imported from India or China. And the patient has no way to know unless they ask the pharmacist to check the bottle that it came in.

Pharmacies are contracted with distributors, and the distributors will often sell the pharmacies the cheapest drugs that they can get – and most chain drug stores cannot get any other brands.

Pharmaceutical companies, when contacted, often do not know the source of the medication because they are international manufacturers. Or, if they do know the source of the drug, they will not tell you – they will say it is proprietary information.

The FDA when contacted also does not give the consumer information as to the Country of Origin even for a BRAND name drug.

Last year, there was a major drug recall of blood pressure prescription drugs due to the presence of two contaminants – NDMA and NDEA.

This is the most current statement from the FDA regarding those medications:

“Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications”

And now, the OTC and prescription drug ZANTAC has also been found to have the contaminant NDMA: “Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines.”

“ISSUE: FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

NDMA and NDEA are listed on the California Proposition 65 website:

NDMA /n-Nitrosodimethylamine:

“Occurence(s)/Use(s)

Research chemical (induces cancer); byproduct of manufacturing processes; component of tobacco smoke. Formerly used as component of rocket fuels.”

NDEA / n-Nitrosodiethylamine:

“Occurence(s)/Use(s)

Gasoline and lubricant additive, stabilizer in plastics, solvent, copolymer softener; precursor to 1,1-diethylhydrazine; emitted during the compounding, forming, and curing operations of elastomeric parts; component of tobacco smoke.”

But this is the thing that scares me the most: “If China shut the door on exports of medicines and their key ingredients and raw materials, U.S. hospitals and military hospitals and clinics would cease to function within months, if not days,” she testified.” Source: “Expert Warns Congress About U.S.

Dependency on China for Medicine.”

“One of the reasons it’s taken years for Washington to take a closer look at China’s dominance of the generic drug manufacturing market is that no American organizations are lobbying against it,” she said.

“There’s no lobby group in Washington area that is advocating, unlike steel, for domestic manufacturing of our generic drugs. And, when there is no industry advocacy, a topic does not reach the high levels that it should,” Gibson said.

However, since the U.S. Senate commission hearing, Gibson is hoping Congress will act:

“I’m hoping that this will rise to the level of executive action. I drafted an executive order for a full government review,” said Gibson, adding that she has selectively shared the proposed legislation with government officials across the political spectrum. “This is and should be a bipartisan issue.”

When I recently mentioned this issue to a member of Congress, and to a State Elected Official, I was told that one person (me) could not do this alone. I had planned to go to AARP.

But I also suggested to the State Elected official that they discuss this issue with the California Medical Association. Can we get the California Medical Association, the American Medical Association, AARP, and other medical organizations, to lobby Congress on this issue to encourage Congress to act on this issue as an emergency?

Please – Congress members:

I ask that you request that the American Drug Manufacturers produce the prescription drugs and their OTC medications for United States consumption in the United States.

I ask that you require the manufacture of the chemical precursor medications to be not only made in the United States, but that stock piles of the chemicals be kept to make sure that when there is a need for a particular drug, that drug does not become subject to a shortage.

(Chris Rowe has been a 41-year resident of West Hills, was a former West Hills Neighborhood Council Board Member, and has a B.S. in health education. While working her way through college, Chris spent about seven years working in hospitals and nursing homes as a nurse’s aide, unit secretary, and as a pharmacy technician. She has worked at Northridge Hospital, the Tarzana Medical Center, and at West Hills Hospital in the 1970s.She can be reached at [email protected].) Edited for CityWatch by Linda Abrams.