The U.S. leads the world in biopharmaceutical manufacturing and Indiana is a key producer with a $99 billion economic impact. In an industry known for highly skilled jobs, Indiana’s life sciences industry directly employs 70,000 people at an average wage of $148,000 - supporting the economy and communities across the state. Medicines made in America must meet rigorous safety standards but not all medicines being sold in the U.S. are held to the same standards, posing a risk to our economy and health.
In the U.S., a biopharmaceutical manufacturing facility must comply with Current Good Manufacturing Practice (cGMP) – a manufacturer registers the products being produced and details about their facility with the U.S. Food and Drug Administration (FDA). The facilities and manufacturing methods are subject to ongoing inspections both by the FDA and by the manufacturer, which must monitor and report any problems and how they are being addressed. This level of safety and quality control is expensive and time-consuming. These facilities cost billions to build and millions more to operate.
Some online pharmacies, many of which operate illegally and unsafely, sell unapproved medicines for weight loss and have recently been flooding the U.S. market. These drugs, and the ingredients from which they’re made, often come from unregistered manufacturing plants in China and India. Uninspected facilities, which don’t have to comply with the same standards for manufacturing and reporting as U.S. plants, can undercut American manufacturing costs, which means jobs in the U.S. are at risk.
In 2022, the incredible demand for medicines to treat diabetes and obesity created a shortage for the FDA-approved drugs. During a shortage, or in other instances where there is a patient need, pharmacies are permitted to create compounded versions of medicines. Compounders can use ingredients to make and sell a medicine without having to go through an expensive clinical trial and have the FDA review their chemistry, manufacturing, and controls for the drug’s production. Compounding is primarily meant to be a temporary solution in a shortage, but online pharmacies took advantage of the popularity of treatments for obesity and built an industry of online, non-FDA-approved medications with slick marketing campaigns and big profits.
Since then, billions of dollars have been invested in U.S. biopharmaceutical manufacturing facilities to resolve the shortage of GLP-1 drugs. Due to that investment, and the efforts of skilled workers in Indiana and other states, the GLP-1 shortage is now resolved. People who need FDA-approved GLP-1 medicines for obesity or diabetes can get them at a pharmacy.
However, the profiteering online pharmacies continue to import ingredients to manufacture and sell low-cost, less-regulated copies of these medicines, and the FDA isn’t stopping it. Most voters want the FDA to protect them against the risks of imported medicines. But drug products from China and India continue to pour into the U.S. and are being sold to Americans through online pharmacies. The people buying prescriptions online do not realize they are getting a potentially unsafe drug. It is time for the FDA to take a real stand.
The FDA needs to enforce the laws of the U.S., where approved medicines are manufactured in facilities that uphold universally recognized standards. If the FDA continues to welcome shipments of ingredients from plants that undercut U.S. suppliers, then the billions of dollars in investment in Indiana’s biopharmaceutical manufacturing sector will disappear. That will cost the state jobs and future life sciences investment.
Our community has the talent and capacity to develop safe and effective medicines and be the beneficiary of new biopharmaceutical manufacturing investment, but that is currently at risk. Compounders using unsafe ingredients, produced in unregulated foreign plants, are a threat to our economy and the lives and health of patients. Once a shortage is resolved, the FDA needs to move swiftly to ensure that compounders do not continue to profit from the hard work and intellectual property of American biopharmaceutical companies.
Kristin Jones serves as President and CEO of the Indiana Life Sciences Association, formerly the Indiana Health Industry Forum. Since her appointment in December 2009, she has led the organization in its mission to support Indiana’s life sciences sector. Under her leadership, the association has grown to represent nearly 250 member companies and has become a key resource for advocacy, networking, and strategic planning within the industry.
