A surge of cheaper custom-made drugs entering the market has spurred a backlash from pharmaceutical companies and federal health regulators looking to thwart these emerging drugmakers, The Wall Street Journal reported.
As drug prices continue to rise, companies are marketing cheaper versions of costly brand-name drugs which they have tweaked and manufactured in large quantities.
The act of developing custom-made versions of expensive drugs is known as "compounding" and allows drugmakers to forego the regulatory process that traditional pharmaceutical companies have to undergo to prove their medicines are safe and efficient, The Wall Street Journal noted.
The U.S. Food and Drug Administration describes compounding as the process of altering or combining certain ingredients to produce a medicine based upon the needs of an individual patient.
Previously, medicines were compounded for patients who could not be treated with other FDA medication due to allergies to certain ingredients.
Now drugmakers are customizing medicines to meet the demand for lower-priced medicines.
One such company is Athenex Inc. in Buffalo, New York, which recently began marketing a compounded version of a popular blood-pressure medication that it sells for up to 35 percent less than the branded version, The Wall Street Journal noted.
However, the FDA is taking steps to halt these drugmakers while traditional pharmaceutical companies have filed lawsuits against them.
The FDA has said serious patient injury is linked to poor quality compounded drugs, which are not FDA approved.
In a statement, the administration drew upon a 2012 incident in which contaminated drugs compounded by a Massachusetts pharmacy led to more than 750 cases of infection and more than 60 deaths of patients in 20 states.
Last month the FDA proposed having certain drug ingredients that can be used for bulk compounding removed from a list, The Wall Street Journal reported.
"If people start taking compounded drugs because of cost, instead of a generic or new drug, that would undermine the premarket approval system," said Julie Dohm, the FDA senior science adviser for compounding. "Those studies and that testing are so critical to knowing that the drug will be safe and effective."
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