National Coalition for Cancer Research
Web site: cancercoalition.org
NCCR is a nonprofit organization comprised of 26 national organizations dedicated to the eradication of cancer through a vigorous public and privately supported research effort.
News and Items of Interest
Following is an article from Inside Health Policy regarding testimony given by NIH Director Francis Collins regarding royalty sharing for drugs developed utilizing basic and/or clinical research funding from NIH.
Collins: NIH Can't Mandate Drug Pricing, But Can Share in Royalties
The National Institutes of Health chief told lawmakers Wednesday (May 11) that the research hub could play a role in ensuring royalty sharing with the drugs it helps develop, but said there is little the agency could do to interfere with steep drug costs, noting that previous efforts to add pricing clauses to NIH contracts failed in the 1990s. Sen. Sherrod Brown (D-OH) raised the issue in the context of NIH's role in developing the pre-term labor drug Makena, the price of which increased dramatically once approved for market, during a Senate appropriations hearing and asked how to avoid similar issues with taxpayer-funded research.
Brown has led the legislative charge against the drug manufacturer KV Pharmaceuticals for significantly increasing Makena's price after using NIH-funded clinical trials to bring the drug to market and receiving orphan drug status, which includes seven years of exclusivity for drugs that treat small patient populations.
NIH Director Francis Collins credited the public outcry from Brown and other stakeholders for bringing corrective action by the company, which later reduced the price and expanded patient aid. Collins said in the 1990s NIH considered attaching a reasonable pricing clause to licensing agreements to avoid similar situations.
"It was a poison pill for any serious relationship that NIH would have with a company," he said during the HHS appropriations subcommittee hearing. "No company in this country or elsewhere would be interested in a partnering with NIH under those circumstances."
However, if a drug firm obtains profits with an NIH-developed drug, there could be royalty sharing, he said. "What we can do is to make sure that if profits ensue, and NIH has made a contribution to that in terms of genuine intellectual property discoveries, that there should be royalty sharing on that basis."
Brown has requested investigations from CMS and the Federal Trade Commission, and at one point floated the idea of tying exclusivity to the amount of investment in drug development, although he has since backed off introducing legislation (see FDA Week, April 15). The Makena pricing controversy raised concerns from Medicaid directors and prompted FDA to say it would not take enforcement action against pharmacists compounding the drug, although the agency continues to monitor the medication.
KV Pharmaceuticals, meanwhile, has ramped up its presence in Washington to defend its exclusivity (see FDA Week, April 29). Before it gained FDA approval, the drug was widely compounded for about $20. Upon entering the market, the company set the price at $1,500 per dose, but later reduced the per-injection cost to $690. The company contends that its manufactured injection is made in safer conditions than the compounded version of the drug.
During the hearing, Brown also questioned a $7.5 million NIH clinical trial to expand indications for the drug.
"Research conducted at the NIH helped lead to a breakthrough drug that has saved the lives of thousands of pre-term babies," Brown said in a statement. "But it's nothing short of outrageous when drug companies exploit the taxpayer-funded research carried out at the NIH to grossly pad their profits. We must work to ensure that what happened with Makena and KV Pharmaceutical -- where a drug company has used taxpayer dollars to price-gouge at-risk pregnant women -- will never happen again."
The president's budget request includes $32 billion for NIH, a 2.4 percent increase over fiscal 2010 levels. The research hub, however, has been the target of Republican spending cuts with one continuing resolution proposal for part of fiscal 2011 proposing a $1 billion reduction.
Following is an article from Health Day regarding a study in the February 10 issue of the New England Journal of Medicine indicating that research funded by the public sector has contributed greatly to the development of new drugs and vaccines approved in the United States.
Health Day article: Many Breakthrough Drugs Come From Publicly Funded Research: Study
Letters supported by ICAN
NCCR's letter dated April 16, 2012 in support of the establishment of a Breakthrough Therapy designation for new drugs
that show a high magnitude of clinical activity early in their development.
Two letters sent to HHS with recommendations on implementing regulations for the provision of the Affordable Care Act which requires health plans to cover routine patient costs associated with clinical trial participation.
To Marilyn Tavenner, Acting Administrator Centers for Medicare & Medicaid Services
To Steven B. Larsen, Deputy Administrator, (CCIIO) Centers for Medicare & Medicaid Services (CMS)
NCCR's letter dated January 15, 2010 in support of maintaining the clinical trials coverage provision in the final health reform legislation currently under negotiations. The letter has been submitted to Speaker Pelosi, Leader Reid and the White House Office of Health Reform.
NCCR's letter dated October 26, 2011 concerning the Dept. of Health and Human Services Advanced Notice of Proposed Rulemaking "Human Subjects Research Protections: Enhancing Protection for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators".