Decreasing the time and cost it takes to develop a drug would lower drug prices, FDA chief Scott Gottlieb said Sept. 11.
If drugmakers used combined-phase—also called seamless—trials, rather than the traditional three phases of study, they would save time, cut costs, and reduce the number of patients who have to enroll, Food and Drug Administration Commissioner Gottlieb said. Seamless trials are increasingly being used for oncology drugs, and the FDA’s Oncology Center of Excellence is taking steps to better evaluate and cultivate this approach, he told attendees at a conference hosted by the Regulatory Affairs Professionals Society.
Developing a new drug takes 10 to 15 years and costs an average of $2.6 billion, Andrew Powaleny, director of public affairs at the Pharmaceutical and Research Manufacturers of America (PhRMA), told me.
But a consumer group has concerns that studying a drug in fewer patients could lead to more safety issues once the drug is on the market. Michael Carome, director of Public Citizen’s health research group, told me he’s concerned that smaller clinical studies will lead to less information about the safety of drugs.
Meanwhile, the pharmaceutical industry generally supports the idea of seamless clinical trials. Mace Rothenberg, chief development officer of oncology for Pfizer Inc.'s global product development group, told me seamless trials have a valuable goal of improving efficiency and shortening times for new market entry.
But Rothenberg said it’s important to recognize that the cost of drug development isn’t the only factor driving drug prices. He said the drug’s impact also is considered when setting its price, such as whether the drug delays disease progression, prolongs life, or cures a disease.
Companies also consider the impact of the drug on the overall health-care system when setting the price, Rothenberg said. So even though some drugs have a hefty price tag, they could be replacing a less effective treatment and the new drug could shorten hospitalizations, he said. Examples of this would be drugs that treat hepatitis C or diabetes.
Read my full article here.
Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.
Learn more about Bloomberg Law and sign up for a free trial.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)