By Newt Gingrich and Joe DeSantis
The Democrats hate President Trump.
The Democrats also hate America’s biopharmaceutical industry, which they plan to tax into extinction with Nancy Pelosi’s new drug plan.
Combine these two hatreds together and you get a new low for the do-nothing Democrats in Congress.
According to reports, Democrats are holding up passage of the US-Mexico-Canada (USMCA) trade deal due, in part, to provisions that would bring Mexico’s and Canada’s rules on intellectual property protection for certain kinds of drugs more in-line with those in the United States.
In fact, these rules were passed in 2009 as part of Obamacare – which received unanimous Democratic support. The fact that these rules are now a problem just shows how far to the left Democrats have lurched.
The rules concern a relatively new type of drugs called biologics, which are more difficult to create and manufacture than traditional drugs. The rules passed in 2009 governed how these biologics were to be regulated under the Food and Drug Administration – including how generic versions of biologics (called biosimilars because they are not exact copies) could be introduced.
One of the standards it created was a 12-year period of “data exclusivity” for new biologics. This is the length of time before generic drug manufacturers can use the original biologics’ data from clinical trials as part of their FDA application for the biosimilar medications. These rules struck a balance between the need to maintain a financial incentive to develop these drugs in the first place and the need to introduce more competition to the market to lower prices.
In the USMCA, Canada and Mexico agreed to significantly increase their own exclusivity periods – nearly matching US standards – with a 10-year period of data exclusivity.
This was a significant victory for the American people, not to mention President Trump, who has made cracking down on foreign freeloading a top priority. It is well established that foreign countries use their single-payer health systems and weak intellectual property protections to underpay for prescription drugs developed and manufactured in the United States. The net result of this exploitation is that US patients subsidize the costs of foreign patients’ medicines.
This is why the Democrats’ insistence on dropping the data exclusivity provisions (which Canada and Mexico agreed to) is so outrageous. Removing these provisions from the USMCA would do nothing to lower the price of drugs in the United States. The same 12-year data protection for biologics established in 2009 would still apply within our borders. The only difference is that Canada and Mexico could approve biosimilars in their markets earlier than the US.
Democrats are literally fighting for the benefit of Canadian and Mexican patients at the expense of American patients. They are also holding up all the other economic benefits that the USMCA would extend to the United States – on behalf of the right of foreign countries to freeload off American patients.
The fact is: There are many steps to lower drug prices — and almost everyone in Washington agrees on them. They include reforms to get the benefit of discounts negotiated by middlemen in the drug supply chain directly to patients at the pharmacy counter, changes to the drug approval process to speed new drugs to market to create more competition, and restructuring the Medicare drug benefit to close coverage gaps and cap out-of-pocket costs. These reforms can be found in bipartisan bills sitting in Congress right now.
But these commonsense steps are getting stuck thanks to the Democrats’ mad rush to impeachment, their burning desire to deny President Trump any sort of victory, and their ideological hostility to America’s private biopharmaceutical sector – which produces more new cures than any other in the world.
If the 2020 election arrives without some sort of legislative progress on reducing drug prices, the American people should know who to blame.