NACDS, HDA speak out against importation of pharmaceuticals
WASHINGTON — The National Association of Chain Drug Stores and the Healthcare Distribution Alliance on Monday submitted a joint op-ed that was published by The Hill regarding the inherent risks of importing drugs from foreign markets.
Allowing the importation of pharmaceuticals from foreign markets is not a health cost panacea, argued John Gray, president and CEO HDA, and Steven Anderson president and CEO NACDS, and in fact would undo current legislation designed to maintain the integrety of the closed pharmaceutical supply chain in the U.S.
"The U.S. pharmaceutical supply chain is a sophisticated, efficient and highly secure system, and in 2013, Congress made a firm commitment to further strengthening it by passing [Drug Supply Chain Security Act]," the association leaders wrote. "This federal law — which was enacted to establish a uniform national framework for tracing prescription medicines — was supported by the entire supply chain," the said. "Pharmaceutical distributors and pharmacies are working daily on implementation, together with their supply chain partners, running pilot programs and establishing comprehensive systems for traceability, data exchange and retention to make our pharmaceutical supply chain more secure."
The op-ed noted that importation threatens the progress the industry and the government have made in collaborating to secure the safety of the domestic pharmaceutical supply chain and would undo all the hard work that has been accomplished since the enactment of DSCSA four years ago.
NACDS and HDA also urged the Senate Committee on Health, Education, Labor and Pensions and other members of Congress to protect patients and the safety of the supply chain, stating: “We, and ultimately the patients we serve, simply cannot afford to risk the entrance of substandard, unsafe medicines into one of the safest and strongest supply chains in the world.”
CNBC: Drug pricing not discussed in White House biomedical meeting
WASHINGTON — Executives from Celgene, Regeneron and Vertex represented the drug industry Monday during a biomedical research discussion, but drug prices, long a concern of President Donald Trump, was not discussed during the two-hour meeting, reported CNBC.
"There's all kinds of elephants, and the room is crowded with them I suppose, but that one didn't get much attention," Dr. Francis Collins, director of the National Institutes of Health, told CNBC in an interview directly after the meeting.
The meeting was attended by Ivanka Trump, Jared Kushner, Health and Human Services secretary Tom Price and Vice President Mike Pence.
"The real intent here was to try to have these various participants in this amazing ecosystem of American biomedicine talk about how all these parts have to fit together in order for the discoveries to continue to roll forward, the medical advances, the cures for disease to continue to happen at a very exciting time in terms of an accelerated pace," Collins said.
To read the CNBC report, click here.
Radicava becomes first FDA-approved ALS drug in many years
WASHINGTON — The Food and Drug Administration approved Mitsubishi Tanabe Pharma America’s Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly referred to as Lou Gehrig’s disease.
“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”
ALS is a rare disease that attacks and kills the nerve cells that control voluntary muscles. Voluntary muscles produce movements such as chewing, walking, breathing and talking. The nerves lose the ability to activate specific muscles, which causes the muscles to become weak and leads to paralysis. ALS is progressive, meaning it gets worse over time. The Centers for Disease Control and Prevention estimates that approximately 12,000 to 15,000 Americans have ALS. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear.
Radicava is an intravenous infusion given by a health care professional. It is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free.
The efficacy of edaravone for the treatment of ALS was demonstrated in a six-month clinical trial conducted in Japan. In the trial, 137 participants were randomized to receive edaravone or placebo. At Week 24, individuals receiving edaravone declined less on a clinical assessment of daily functioning compared to those receiving a placebo.
The most common adverse reactions reported by clinical trial participants receiving edaravone were bruising (contusion) and gait disturbance.
Radicava is also associated with serious risks that require immediate medical care, such as hives, swelling, or shortness of breath, and allergic reactions to sodium bisulfite, an ingredient in the drug. Sodium bisulfite may cause anaphylactic symptoms that can be life-threatening in people with sulfite sensitivity.
The FDA granted this drug orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.