HHS Pharmaceutical Pricing Forum: Lots of Questions, Few Definitive Answers

The Department of Health and Human Services (DHHS) Friday invitation Pharmaceutical Forum was more of a listening session for a wide range of stakeholders to explain the concerns and discuss a number of possible ways to reduce drug prices, including some Food and Drug Administration (FDA) reforms involved.
HHS Secretary Sylvia Burwell began pointing event the steep increases in drug costs, particularly for specialized medicines, which accounted for approximately $ 87 billion in 2012, or about 25% of total expenditure on drugs US States and could quadruple by 2020.

But the complex problem of ensuring companies remain innovative while providing access to affordable medicines is what motivates the discussion.

"As we work to find the right balance between promoting innovation and keep them accessible and affordable medicines, we must let the principle of putting the consumer at the center of the guide our thinking," Burwell said.

FDA Action

 

Although Burwell disregard the progression of the Senate version of the Act Cures the 21st century, which could include significant changes to the FDA, he said the FDA is looking at ways to accelerate accelerated system of drug development and improve the process examination.

Focusnoted And earlier this week, much of the discussion about the price of drugs and the FDA continues to focus on faster approval of generic drugs and the beginning of a robust market for biosimilars.
Both Steve Miller, MD, Senior Vice President and Chief Medical Officer of Express Scripts and Chip Davis, president and CEO of the Generic Pharmaceutical Association, criticized the FDA for approval of slow rate abbreviated new drug applications (ANDA) and a large portfolio order.

Similarly, Doug Long, vice president, IMS Health said the delay ANDA "is higher than it has ever been" and the FDA has "yet to take a slap at her."

Long also mentions the prospect of biosimilars drop drug bill United States, but said the price is not going to become really competitive as several companies have marketed biosimilars for the same reference product, which probably will not go through a couple of years.

On the subject of the second round of negotiations to user fees for generic drugs (GDUFA), Davis also noted that so far, he felt like a "workspace" if he said he remains optimistic.

Value

 

The question of the actual value of the world of drugs has emerged several times during the forum, and this is an issue that seems to be rampant not only in the US (As the New England Journal of Medicine reported), but other countries and especially with the new anticancer drugs.

Merck CEO Ken Frazier said one face of the challenges that the industry is limited by the tools they can use to talk about certain advantages in the world or the real risks that are not included on the label of a drug.
"Sometimes, in order to have a good idea of ​​what the benefits / risks, we must look beyond the label, but we are limited by FDA regulations," Frazier said.

Similarly, Mark McClellan of the Brookings Institution has called for political reforms that promote the development of valuable treatments and discourage high prices that do not reflect the value and could lead to excessive and unnecessary expenses.

And although the forum has launched a, the strongest national conversation about drug prices and potential pricing based on the value or result-oriented and purchase - what is clear is how HHS plans to take measures and where it could begin.

"This is a complex issue and there is no single solution," Meena Seshamani, Director, Office of Health Reform at HHS, said after the forum.