Trump signs industry-backed legislation ending ‘gag clauses’
President Trump today signed the Patient Right to Know Prices Act (S. 2554) and the Know the Lowest Price Act (S. 2553) at a ceremony today at the White House.
Among those in attendance at the bill signing ceremony were National Association of Chain Drug Stores president and CEO Steve Anderson; NACDS vice chairman and executive vice president of Wakefern Food/ShopRite, Chris Lane; and NCPA CEO B. Douglas Hoey.
The bills will help patients save money on prescription drugs by ending so-called “gag clauses” that prevent pharmacists from telling patients about instances in which they could save money by paying cash out-of-pocket instead of using their insurance benefit. S. 2553 pertains to Medicare Part D and Medicare Advantage, and S. 2554 pertains to private plans.
In addition, S. 2554 includes a separate NACDS-backed provision that requires the Federal Trade Commission and the Department of Justice to be notified of any biosimilars patent settlements, as a way to prevent such agreements from delaying patients’ access to lower-cost drugs.
“NACDS applauds the focus and the determination that the Trump Administration is bringing to the work of reducing patients’ out-of-pocket drug costs, and we appreciate the diligence of these bills’ Congressional sponsors in leading this legislation all the way to the President’s desk,” Anderson said.
Prior to signing the bills President Trump said, “I’m thrilled to sign two bills that will lower the cost of prescription drugs. Earlier this year I released our drug pricing Blueprint, setting out a new agenda to drive down drug prices. Within a week of releasing the Blueprint, my administration started to crack down on so-called ‘gag clauses’ in Medicare Part D plans. These clauses prevent pharmacists from telling patients about more affordable options for prescription drugs.”
At the ceremony, Health and Human Services Secretary Alex Azar extended President Trump’s gratitude to the members of Congress and the Senate for passing “these two very important pieces of legislation that end pharmacy gag practices, which prevent a patient from knowing they can pay less for drugs. Now you can ask your pharmacist, can I pay less for this medicine than what my insurance is going to pay? That is an important right and it shows that with drug pricing we can work in a bipartisan way because we have to get drug prices down.”
Azar continued, “Thanks to the President’s leadership we have already taken major action since the President rolled out his Blueprint. We’re creating a pathway for importation of drugs to relieve exorbitant price increases of generic drugs and other branded drugs in the U.S. that are off patent. He’s also brought increased competition to generic approvals at historic levels and ended gaming by branded companies to prevent the entrance of new generic drugs. This is just the tip of the iceberg. In the weeks and months ahead we have so much more coming from the regulatory aspect to break down the price of drugs in this country.”
“NACDS has engaged strongly in the current focus on bringing about policies that enhance the affordability of prescription drugs, which studies have shown is a key factor in whether patients will take their medications as prescribed and thus play a critical role in their own health and wellness. Current efforts build on pharmacy’s role as a long-standing and trusted partner for patients and for government leaders seeking workable solutions,” NACDS said.
A January 2018 national survey conducted by Morning Consult and commissioned by NACDS found that eight-in-ten respondents said pharmacists are credible sources of information about how to save money on prescription drugs. “That is the highest rating of all healthcare professionals tested. This new law will provide pharmacists with another opportunity to help patients enhance the affordability, and thus the effectiveness, of their medication therapy – and we look forward to the continued dialogue and work with the Trump Administration and with Congress,” NACDS said.
Sen. Susan Collins, R-Maine is the lead sponsor of S. 2554 and an original co-sponsor of S. 2553. Sen. Debbie Stabenow, D, Mich. is the lead sponsor of S. 2553 and an original co-sponsor of S. 2554. Serving as original co-sponsors of both bills are: Sens. John Barrasso, R-Wyo., Bill Cassidy, R-La., and Claire McCaskill, D- Mo. In addition, Sen. Ron Wyden, D-Ore. is an original cosponsor of S. 2553.
In the U.S. House of Representatives, Rep. Buddy Carter, R-Ga. introduced the Know the Cost Act (H.R. 6733), which applies to both Medicare and private insurance. The U.S. House of Representatives Committee on Energy and Commerce passed that legislation on September 13. The House ultimately passed the Senate legislation on September 25 to fulfill the requirement that both chambers must pass a bill in identical form for it to be signed into law by the President.
Paratek gets FDA green light for two drugs
Paratek Pharmaceuticals has received the FDA’s blessing for Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia, or CABP, and acute skin and skin structure infections, or ABSSSI.
The product, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and drug-resistant strains.
“In the face of ever-increasing antibiotic resistance, the FDA approved Nuzyra with a label having full approval for both CABP and ABSSSI. We are excited to bring to physicians an effective, well tolerated monotherapy option for patients,” Paratek president, COO, and chief medical officer Evan Loh said in a statement. “Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays.”
“The approval of NUZYRA is an historic milestone for Paratek as it represents 20 years of research and development of this life-saving antibiotic for patients affected by community-acquired infections,” Paratek chairman and CEO Michael Bigham said in a statement.”There are countless champions of Nuzyra who have been tireless in their efforts to ensure its advancement to commercialization — from patients, clinicians and study investigators to our Paratek team. We are grateful to all who played a role in making NUZYRA available to patients in need. We are excited to launch Nuzyra early next year.”
In a separate development, Paratek also received the FDA’s nod for Seysara (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of old and older.
The product is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate-to-severe acne in the community setting.
Paratek has exclusively licensed U.S. development and commercialization rights of Seysara for the treatment of acne to Allergan, who has assigned such rights to Almirall SA. Paratek retains development and commercialization rights in the rest of the world.
FDA green lights Insmed’s Arikayce for lung disease
The Food and Drug Administration has cleared Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex, or MAC, in a limited population of patients with the disease who do not respond to conventional treatment.
MAC is a type of nontuberculous mycobacteria commonly found in water and soil. Symptoms of disease in patients with MAC include persistent cough, fatigue, weight loss, night sweats, and occasionally shortness of breath and coughing up of blood.
“As bacteria continue to grow impervious to currently available antibiotics, we need to encourage the development of drugs that can treat resistant infections. That means utilizing novel tools intended to streamline development and encourage investment into these important endeavors,” FDA commissioner Scott Gottlieb said.
“This approval is the first time a drug is being approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, and it marks an important policy milestone,” Gottlieb said. “This pathway, advanced by Congress, aims to spur development of drugs targeting infections that lack effective therapies. We’re seeing a lot of early interest among sponsors in using this new pathway, and it’s our hope that it’ll spur more development and approval of antibacterial drugs for treating serious or life-threatening infections in limited populations of patients with unmet medical needs.”