Dr. Gott: Where do our drugs come from?
DEAR DR. GOTT: How can we know the source (country and producing company) of drugs?
Ordering drugs through an online company outside the United States, I’ve noted they have come from Germany but are of Indian origin. Are they equivalent to U.S. manufactured drugs and specifications?
I’ve heard U.S.-made drugs may have components produced overseas, so how do we know if drugs like this are safe? Does the FDA have any jurisdiction over ingredients made elsewhere for inclusion in U.S. pharmaceuticals?
DEAR READER: According to a Consumer Reports article from two years ago, the FDA requires a drug’s original packaging to list the name and address of the company that manufactures, packs or distributes a product. Unfortunately, this information often refers to over-the-counter (OTC) drugs, because most prescription drugs are rebottled and relabeled at your local pharmacy.
Many people obtain a one-month supply at a time. Those prescriptions that call for, let’s say, 100 tablets may get a factory-sealed original package of 100 pills with the pharmacy labeling affixed. Even in the instance of an OTC in lesser amounts, the information may reveal only where the drug is processed and packaged, not where the ingredients come from.
I understand that a person can contact the manufacturer of most drugs to determine where it is manufactured and will receive a satisfactory answer; however, this may take several days, and a patient may choose to begin a medication faster than that.
Manufacturing costs, ingredients and labor may be substantially cheaper in other countries. Beyond that, the FDA appears to inspect domestic facilities more frequently than foreign facilities – another reason why drugs manufactured and packaged here are higher in cost.
One New York Times article covered by Consumer Reports indicated the critical ingredients for most antibiotics, prednisone, metformin, hypertensive drugs and others are now manufactured almost exclusively in China and India. The article went on to note that the Chinese government has been investing huge sums in penicillin fermenters, “disrupting prices around the globe and forcing most Western producers from the market.”
The Centers for Disease Control and Prevention purportedly has a stockpile of medicines with enough antibiotics to treat 40 million people. However, if more medicine is needed, the nation simply doesn’t have the plants to produce them, and it would take two years to begin production all over again.
Consumers Union, the parent of Consumer Reports, is working with congressional leaders on a bill that will require the FDA to provide tighter scrutiny of foreign manufacturers and imported drugs destined for the U.S. This legislation presumably will also require foreign manufacturers and suppliers to be registered since, in some instances, the FDA isn’t even aware of who is making what, and to permit inspectors to make unannounced inspections every two years! I guess this is an improvement, since the current inspection level is 10 or more years in some countries.
What a dilemma. My advice to you is to make a list of your medications. Telephone or otherwise contact the suppliers to request the information you feel is relevant. Determine if the drug or drugs and all ingredients are manufactured, packaged and distributed within the United States without any outside input. If you are dissatisfied with the answers presented, do your homework to find out if a comparable medication is available here and meets your standards. Good luck!
Readers who would like related information can order my Health Report “Consumer Tips on Medicine” by sending a self-addressed, stamped No. 10 envelope and a $2 U.S. check or money order to Dr. Peter Gott, P.O. Box 433, Lakeville, CT 06039. Be sure to mention the title), or print an order form from my website’s direct link: www.askdrgott md.com/order_form.pdf.
Dr. Peter H. Gott is a retired physician. His website is www.AskDrGottMD.com.