Saturday, June 30, 2018
REVAMP - Its Here!!
And its called REVAMP (re-valuing antimicrobial products). This bill, proposed in the US House of Representatives by Rep John Shimkus, R-Ind. and Rep Tony Cardenas, D-Calif. represents the most important advance in pull incentives since we began discussing them. AND – its my preferred incentive – a transferable exclusivity voucher. They express it differently – they call it an exclusivity conveyance but it adds up to the same thing. If a company gets an antibiotic approved and that new product addresses a priority medical need as determined by the CDC priority list, the company would receive up to 12 months additional exclusivity on that product. BUT – that additional exclusivity must be conveyed (transferred) to another product or products. It looks like the exclusivity could also be “conveyed” to other parties – “the holder of a conveyed exclusivity extension period may sell, exchange, convey, or hold for use, such period.”
This incentive is extremely effective because it could be worth billions of dollars. And, because it is transferrable between companies, it provides an incentive for investment in start-ups and biotech since large pharma will have a strong incentive to license any product that meets the CDC and HHS criteria.
There are a few conditions for the award –
§ Ensure availability of product for susceptibility device manufacturers
§ Identify, track and publicly report product resistance data and trends
§ Develop written guidelines and procedures for products appropriate use, which includes appropriate promotion practices, education, surveillance, monitoring and stewardship.
§ Develop education and communications strategies for health care professions about appropriate use
§ Submit a stewardship activity assessment to agency every two years
§ Contribute five percent of the total value of consideration received from the conveyance to the Foundation for the National Institute of Health for early stage antimicrobial research.
The justification for the conveyance of exclusivity to products other than antibiotics is simple. Many other therapies depend on our ability to treat infections. Without this, the treatment of cancer, autoimmune disease including arthritis, and simple routine surgeries become much higher risk. The risk of wounds of war also would take us back to civil war days without effective antibiotics.
The bill is limited to 10 such awards. After the fifth year post-enactment or the fifth award, whichever should come first, the GAO is to evaluate the effectiveness of the program for developing priority antimicrobials, and shall examine the indications, usage, development of resistance and overall societal value of the priority products that have received this award.
It is impossible to judge how much this blog and your efforts contributed to this decision. But I notice that the blog has received a large number of views from Washington and Arlington over the last several weeks. That is very unusual and I suspect that congressional staffers are paying attention.
Now, we must push our representatives in congress to vote for this bill! Please, once again, contact your representatives and express your strong support for this bill!