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.
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