Making and Integration Drug Affordability Systems

Abstract:
The FSA was formed by an executive order by Franklin Delano Roosevelt on April 25th, 1939.
The FSA created many other agencies under it. Although its time came to an end in 1953, many
of the organizations that came under its purview still lived on. Of these, the FDA, or Food and
Drug Administration is of interest. With the development of new and more powerful drugs,
patients would hope that treatments for more conditions would become widely available. Instead,
corporate interests seek to maximize profit over the potential social benefit.

The M.I.D.A.S. bill’s goal is to create a sustainable solution that will ensure innovation
continues, but rewards corporations that prioritize social benefit over maximizing profits. The
solution is intended to hurt the consumer in as little ways as possible. M.I.D.A.S does not
implement tax hikes, rather it adds regulation to the industry. Rather than forcing broad
healthcare reform, the solution starts at the industry level and distribution level to help reduce
one part of the problem: exorbitant drug prices.

1. Drug Patenting Practice Regulation

a. All drugs regulated by the FDA may only have a singular patent associated with it
that encompasses all to do with that drug including but not limited to: research
and development, medical trial process, and fabrication process
b. No additional patent filings for an individual drug can be made that effectively
extend the original patent’s duration
c. Upon violation of the previous clauses, the drug is not permitted to come to
market
2. Chemical Drugs and Generic Exclusivity Regulation
a. The base exclusivity for chemical drugs are as follows:
i. New Chemical Entity - 3 years
ii. Orphan Drug - 4 years
iii. New Clinical Investigation - 1 year
b. Pharmaceutical companies may apply for exclusivity extensions if they can prove
and maintain during all exclusivity periods and extensions any of the following
i. DTC advertising for product under 50 million dollars per year - 2 years
extension
ii. Drug Price is no more than suggested by the Drug Price Advisory Board
(below) (including any rebates/deals with pharmacies/distributors/etc.) - 3
years extension
 c. After an exclusivity period is over, and the first ANDA is filed, if that generic
company meets the following requirements, they can get a 1 year exclusivity
period:
i. Launch a lawsuit against the patent from the brand-name reference drug
ii. Go to market at a cost that is 40% or lower of the reference drug
iii. No settlement is made that shares the exclusivity with the original
brand-name manufacturer
3. Biologic and Biosimilar Exclusivity Regulation
a. The base exclusivity for biologics is 7 years
b. Pharmaceutical companies may apply for exclusivity extensions if they can prove
and maintain during all exclusivity extensions any of the following
i. DTC advertising for product under 50 million dollars per year - 3 years
ii. Drug Price is no more than suggested by the Drug Price Advisory Board
(below) (including any rebates/deals with pharmacies/distributors/etc.) - 4
years
c. ANDA streamlining for Biosimilars
i. The current process for proving biosimilarity is arduous and expensive,
which provides significant barriers for entry in the market with biosimilar
companies, so the current system will be reviewed and revamped
d. After an exclusivity period is over, and the first ANDA is filed, if that biosimilar
company meets the following requirements, they can get a 2 year exclusivity
period
i. Launch a lawsuit against the patent from the brand-name reference drug
ii. Go to market at a cost that is 40% or lower of the reference drug
iii. No settlement is made that shares the exclusivity with the original
brand-name manufacturer
4. Drug Price Advisory Board
a. The Drug Price Advisory Board will be a committee formed by leaders of the
FDA
b. The Board will be responsible for the overseeing prices of drugs in a way that is
considered fair and just to consumers
5. Drug Pricing Transparency
a. When a drug is deemed safe to market by standard FDA practices, the
pharmaceutical company must provide the FDA with a document containing
information regarding the derivation and reasoning for the price of the drug. The
document must contain information including but not limited to:
i. Accurate and precise meeting minutes and briefs
 ii. Accurate and precise relevant statistics
b. This document must accurately and precisely reflect the internal company
discussions
i. Must be supported by meeting briefs, etc
ii. Must be supported by exact statistics
c. Upon review of this by the aforementioned Drug Price Advisory Board, if the
pricing is deemed acceptable by the FDA, the document will be posted for the
public to view and the drug can go to market
d. If a company is found to intentionally obfuscate or hide reasonings, they will be
fined for 1000 times the expected treatment cost, defined as the sum of the full
treatment at their suggested list price
i. Eg. If a single pill is listed at $50, but the full treatment requires 10 pills a
month for 1 month, the “Expected treatment cost” is $500