Opinion

Legislation Threatens Patient Confidence in Biologics, Slows Biosimilars

In the remaining days of this divided Congress, one issue that is uniting policymakers is the need to improve our system for getting low-cost quality-assured therapies to patients quickly. Yet one proposal included in a Senate bill would impede that goal by exempting biologic medicines – including biosimilars, insulin, blood thinners, cancer treatments and other drugs – from having to comply with public standards for quality.

The bill, called the FDA and NIH Workforce Authorities Modernization Act, was recently approved by the Senate Committee on Health, Education, Labor and Pensions and may soon be considered by the full Senate. The House version of the bill, known as the 21st Century Cures Act (HR 6), passed last year, without the provision.

We are concerned about the impact that this Senate provision could have on patient safety and public health and believe that it would undermine medication quality and integrity in America.  If enacted, this provision would make it more difficult for public health officials to test the quality of biologic drugs across the supply chain, hinder the development of biosimilars and thereby increase costs for payers, and remove the transparency and collaboration that now exist in standard-setting.

Currently, quality standards for medicines in the U.S. are established by the USP (U.S. Pharmacopeial Convention), a nonprofit organization governed by 450 member organizations representing a wide spectrum of science and public health stakeholders.  For nearly two hundred years USP, through an unbiased, scientific process, has developed the public quality standards that help to ensure the quality and integrity of medications in the US.   Since 1906, federal law has required that all medicines in the U.S. to comply with these standards.  America’s medicine supply is among the safest in the world, in part because of mandatory compliance to USP’s public quality standards.

Simply put, the provision at issue would remove the existing requirement that biological medicines comply with the public quality standards established by the scientific expert committees of the USP. In the absence of USP public quality standards, the only quality protections would be the private specifications for a single product developed by its manufacturer and the regulator.  These would not be available publicly.

We urge those who are drafting the Senate version of the House bill to explore the unintended consequences of this provision. Only a small number of stakeholders were given an opportunity to provide input to the provision; we believe that a thorough consultation with other affected stakeholders and an evaluation of the successful track record of public quality standards in protecting patient safety will lead to the conclusion that compliance to these standards should remain a requirement for medicines marketed in the US.

Advocates for this provision have said they believe it will expedite the development of biosimilars – which are versions of biological drugs that are similar to, and serve the same therapeutic goal, as original innovative biological drugs. While these advocates are well intentioned, there is no evidence that USP’s public process has ever created a delay. On the contrary, USP standards have been shown to facilitate the development of follow-on products after an original innovative product’s patent expires—this has been seen time and again in the generic drug area.

The recent legislative proposal came about as patents are starting to expire on existing biological drugs and many manufacturers are developing biosimilars. We agree that more biosimilars are needed to create competition and provide more choices and better access to therapies. Improved access to biosimilar drugs in the U.S. is estimated to save the U.S. healthcare system up to $44 billion over the next ten years. USP’s public quality standards support the development of new biosimilars because they provide manufacturers with a public quality benchmark in their product development.

The public nature of USP’s standards makes it possible for quality to be tested by anyone at any point in the supply chain. With global manufacturing a reality, this is especially important. The first biosimilar approved in the U.S., for example, is made in Austria and packaged in Germany, and many biological medicine companies have major operations in India.

In the absence of public standards, there only would be the private specification between a manufacturer and the FDA, and third parties such as global health purchasing organizations, law enforcement, distributors and pharmacists would be deprived of an essential tool for identifying counterfeit and substandard drugs and ensuring the quality and safety of medicines.

It is essential that healthcare providers and patients trust that the innovative and biosimilar medicines available in the U.S. are of high quality. Dismantling public quality standards and allowing biologic drugs to bypass crucial requirements threatens to destroy confidence in prescription drugs and endangers our health and safety.

Ronald T. Piervincenzi is the Chief Executive Officer of the United States Pharmacopeia (USP). USP, founded in 1820, is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

Thomas E. Menighan is the Executive Vice President & Chief Executive Officer of the American Pharmacists Association (APhA) Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians as members.

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