Today, the House Energy & Commerce Committee’s Subcommittee on Health will meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. This hearing comes at the same time members of Congress are considering the reauthorization of the user fee programs, the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III). The U.S. Department of Health and Human Services’ transmittal of the proposed PDUFA VII and BsUFA III packages to Congress in January marked the beginning of the legislative phase and an important mi ..read more

Medicare Part B covers a wide range of health care services, including physician office visits, hospital outpatient care and medical equipment. It also covers medicines that are usually administered by a physician, like many medicines administered by injections and infusions. Many of the medicines covered by Part B are for serious and complex conditions, such as cancer, rheumatoid arthritis and mental illness, among others ..read more

Research has shown that 340B hospitals are more likely to prescribe more expensive medicines and significantly mark up the price of medicines. For example, 340B hospitals received nearly five times what they paid, on average, to acquire oncology medicines through 340B. These practices have implications for what patients pay out of pocket — and new research adds to the evidence. A new Milliman analysis found 340B hospitals have lower utilization of biosimilars than non-340B hospitals among their commercially insured patients, potentially leading to higher out-of-pocket costs for some patients ..read more

There has been a lot of talk recently about the biosimilars marketplace and what role biosimilars play in reducing health care costs. We’re here to set the record straight about how these medicines are reshaping America’s health care landscape and improving patient and provider choice ..read more

Biologics are medicines that are made from living organisms through highly complex manufacturing processes and include a wide variety of medicines such as therapeutic proteins, monoclonal antibodies and vaccines. They are used to prevent or treat a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis and autoimmune disorders.   ..read more

America relies on the U.S. Food & Drug Administration (FDA) to keep pace with the scientific advancements happening every day in labs across the country. That’s why the recently enacted Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Act (BsUFA III) are both great news for biopharmaceutical innovation and for patients. With these programs reauthorized for another five years, the FDA can continue doing its vital work reviewing medicines.  ..read more

As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline ..read more

Last month, I presented at the U.S. Food and Drug Administration’s (FDA) Public Hearing on Facilitating Competition and Innovation in the Biological Products Marketplace. The hearing was part of an ongoing dialogue with health care stakeholders and the FDA on the Agency’s efforts to promote innovation and competition in the biologics marketplace. PhRMA is dedicated to helping achieve that balance, which is reflected in our comments on the Biosimilars Action Plan and other related topics submitted to the Agency ..read more

Discussions about spending in Medicare Part B, including a recent report from the Medicare Payment Advisory Commission, or MedPAC, too often overlook how competition between medicines drives down the program’s costs. This competition in turn helps control costs for seniors and people with disabilities who rely on Part B to access their medicines ..read more

Today, the House Energy and Commerce Subcommittee on Health will be hosting a markup session on the comprehensive legislative package to reauthorize the human drug user fee programs, including the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III). In February, PhRMA had the opportunity to testify before the subcommittee on how both programs have played, and will continue to play, a significant role in sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the reg ..read more