Recent developments in the biopharmaceutical world have ushered in a new era of innovation to the great benefit of American patients. New, groundbreaking, highly effective prescription drugs have become available to treat diseases such as arthritis, psoriasis, cancer and Crohn’s.
Biologic drugs, made from living organisms unlike traditional small molecule pharmaceuticals, hold incredible promise for the future of American healthcare. However, two major factors — safety and cost — will determine whether doctors can effectively utilize them to treat their patients, and whether patients fully embrace these medicines in the coming years.
Congress passed the Biologics Price Competition and Innovation Act in 2009, and as its name suggests, it was intended to strike an appropriate balance between innovation and access, as the Hatch-Waxman Act for generic drugs had done nearly 30 years earlier.
Most important, it created a pathway for the approval of biosimilars in the United States, which are medically equivalent versions of biologics which would compete with innovator drugs after a 12-year market exclusivity period. Europe, which approved its first biosimilar in 2006, has already saved tens of billions of dollars through competition between biosimilars and biologics.
Competition drives down costs and provides both physicians and their patients with choices, a critical component of a functioning free market. However, confidence in safety and quality is an essential part of this availability of choice, and of the willingness of doctors to prescribe certain medications and pharmacists to fill those orders.
The U.S. relies on a similar system to the European Union. Drug safety, quality, and efficacy are overseen and ensured by an independent agency, using scientific standards developed by researchers and industry experts. This system has functioned smoothly for decades in the United States and contributes to a more robust competitive market.
Unfortunately, language has been included in a piece of legislation currently moving through Congress, the Lower Health Care Costs Act (S.1895), which would strip the requirement for biologic medicines to adhere to existing standards set by independent experts. The proposed language in S.1895, Section 207, could put patient safety at risk and undermine manufacturers’ ability to bring competing products to market, which could keep prices high for consumers.
These standards, many of which are called monographs, are not created until after the Food and Drug Administration has already approved a drug for sale in the United States, and therefore cannot impede the regulatory approval process. These standards have also been adjusted in recent years by the experts who develop them, which can now better account for the complexity of the medicines to which they apply.
While there is, unfortunately, a myriad of factors which do obstruct the entry of biosimilars into the United States’ market, the existence of independent, scientifically informed safety standards is not one of them. In fact, manufacturers of competing drugs use the public standards as benchmarks to develop their own products, speeding up their own market entry to the direct benefit of American patients who are seeking new approaches to address soaring drug costs. In fact, a recent RAND study estimates savings from biosimilars to reach as much as $150 billion over a 10-year period.
Section 207 seems to be a solution in search of a problem. It is supported by neither the pharmaceutical industry nor the pharmacy community, and it would put an increased strain on the FDA at a time when the agency should be hyper-focused on approving new drugs to compete in the U.S. market, without sacrificing quality or safety.
If prescription drug legislation is going to advance this year, the Senate would be wise to move the bill along without Section 207.
