Help from the board please......
We have Singer on the legal front, our board attorney on the ethics front and now I believe we need to open a path to resolution through regulatory relief. Here is where I need help.
1) Please edit, I am not a lawyer and just dotted down thoughts to close some loopholes. Whats in it for Amarin is in part II and III.
2) Once we agree, I need someone to post this on change.org. I can sign petitions but in my fed position would need approval from our ethics department to post. That will take weeks
3). Once posted on change.org we each promote it to our friends and family to get signatures. We can even pay fees to have them promote it. I think it costs $8.00 per promotional campaign and I will gladly buy a few.
4) Wait a week, and then each of us send it to our Senators and representatives. I think if it gains a million signatures it is sent to POTUS.
This is worth a try since medicine, foreign supply and pharmaceuticals are the hot topic of the day.
Americans for Pharmaceutical Relief Act
America must strive for innovation and leadership in the field of medicine and pharmaceuticals. The Hatch-Waxman act, while well intended has actually increased pharmaceutical expense and risk to innovation. This places American lives in jeopardy. A pharmaceutical company can file and receive a patent(s) from the USPTO and complete an expensive clinical trial where hundreds of millions of dollars are spent to prove the safety and efficacy of the drug. According to an MIT study, only 14% of drugs taken through clinical trials receive regulatory approval. If a drug is approved in the US, foreign generic suppliers can apply for approval to the FDA under Hatch-Waxman and the pharmaceutical that invented the drug, bore the expense of the clinical trial must defend the patent in court or have their innovation stolen by the foreign generic. To avoid a trial, many pharmaceuticals settle with the generic company and that cost is passed to consumers. Companies settle rather than run the risk that judicial activism can strip them of their innovation. Those that do go through trial must pass the cost to consumers. The cost, and risk to a pharmaceutical hinders innovation and increases the cost to consumers. The act is a means to bolster Hatch-Waxman by providing innovators alternatives that resemble some of the regulations in Europe.
Provisions of the Act
Any pharmaceutical company can apply for 10 year exclusivity. Upon drug approval, the company will be granted exclusivity but must adhere to the following requirements to maintain exclusivity:
• If the drug is already on the market in Canada or the EU, the company agrees to price the drug at the same price, or the average if the drug is sold in both the EU and Canada adjusted to US currency (pricing parity).
• If the drug is available in the US market only, the pharmaceutical agrees to maintain pricing and can only increase the prices at the rate of increase in the CPI (consumer price index) each year.
• Each year the company holds pricing (no increase) four additional months of exclusivity will be added to the drug.
• When the drug is approved for additional indications, the drug will receive one additional year of exclusivity.
• A drug cannot receive more than 5 years of additional exclusivity, or 15 years from the date of initial approval.
• Once the drug becomes available in Canada or the EU, pricing must be based on pricing parity in those markets and ineligible to CPI increases. However, exclusivity increases are available for years in which the price is not increased.
• Companies that exit the 10 year exclusivity, or fail to perform under the provision will be subject to the applicable provisions of Hatch-Waxman
• Once a company completes the exclusivity period the applicable provisions of Hatch-Waxman Will apply.
• During the exclusivity period, a generic version of the drug cannot be approved for any condition.
The provisions of this act apply to companies that have an approved patent from the USPTO, and completed a clinical trial to prove safety and efficacy as recognized by the Food and Drug Administration (FDA). A patent invalidated from a court does not affect exclusivity since the drug proved its safety and efficacy under an approved patent from the USPTO.
Provisions for products already approved
Any company that has an approved drug sold in the US market can apply, and receive this exclusivity and must comply with the provision.
• For drugs approved for multiple indications, the company will select the date of approval for its latest indication as the start of the exclusivity period.
• Once approved, the FDA will withdraw approval of any generic version of the drug for all indications. If a generic is on the market, the withdrawal will take place within 90 days to allow the generic to exhaust supply. The 90 days will be added to the drug makers’ exclusivity period.
Consumer Pricing and Protection Provision
According to US FDA regulation, a generic drug must be “therapeutically equivalent” and not Bioequivalent. The safety and efficacy has not been proven for the therapeutic generic compared to the branded drug. Over the years numerous examples of price fixing has hurt consumers and increased drug costs versus savings promised by generics. Quality and supply is also a concern. To promote competition and ensure quality and supply of all drugs insurance companies will be required to:
• Apply the same co-pay requirement to a branded drug as a generic if the branded drug is equal or less than the generic.
• Provide consumers the option of requesting the generic drug or the branded drug if the branded drug is equal to or less than the generic.
• Included branded drugs in the same tier as the generic if the branded price is equal to or less than generics.
