Unauthorized Spending Accountability Act

Floor Speech

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Mr. CARTER of Georgia. Mr. Speaker, I commend Representative Yoho for holding this Special Order on executive overreach.

As a lifelong healthcare professional and former businessowner, I believe the healthcare industry is flooded with examples of President Obama's administration overreaching its authority and either ignoring congressional intent or refusing to enforce laws enacted by Congress.

As recent as last Monday, April 18, the FDA issued new guidance related to the Drug Quality and Security Act and compounding pharmacists.

On November 27, 2013, President Obama signed the Drug Quality and Security Act, DQSA, into law. Within the DQSA, several important provisions were related to the oversight of compounding human medications.

In fact, DQSA created two types of compounding pharmacies, 503A pharmacies and 503B pharmacies. 503A compounding pharmacies are small, community pharmacies that only compound small quantities of medication to a very limited number of doctors and patients with very specific needs.

A perfect example of this is a servicemember who has lost a limb in war. Some servicemen and -women who have lost their limbs experience significant amounts of pain that regular medication does not adequately address. Compounded medication helps with this specialized need.

503B compounding facilities are those outsourcing facilities that manufacture compounded medications and ship them all over the country.

When Congress debated DQSA, many statements were made by both House and Senate congressional Members stating that there was no intent for this bill to restrict State pharmacy licensing boards and their local control of small, community pharmacies.

In fact, the FDA was directed by Congress that, in regards to inspection standards, 503B facilities would be the only ones subjected to good manufacturing inspection standards. You would think that that would make sense, that only manufacturing facilities would be subjected to good manufacturing practice standards.

In addition, congressional intent was clear that 503A community pharmacies could continue to provide office-use compounded medication as they had always done. Did FDA adhere to the obvious congressional intent of DQSA related to compounding? No.

FDA's recent guidance states that all medication that is compounded by small, community pharmacists needs to have a specific patient prescription.

Your local dermatologist, who keeps a local anesthetic in the office to remove skin to test for cancer, is going to have to write a prescription, have the patient go to the pharmacist, get their prescription filled, and then schedule another appointment before checking to see if they have skin cancer.

This goes against all congressional intent, to allow State pharmacy boards to continue local control of their small pharmacies. Now, all State pharmacy boards that allow office use have had their powers taken away from them.

The FDA guidance also pointed out that, except under certain circumstances, good manufacturing inspection standards will always be used to inspect all compounding pharmacies.

So pharmacists who provide specialized compounded medication to one patient with a specific need will be subjected to large corporation inspection standards that will cost significant financial investments.

In essence, the FDA has ignored congressional intent related to the DQSA and has ultimately eliminated an entire sector of the healthcare industry that was providing specialized care to patients with special needs.

In fact, the HHS informed my office that, if we continue to pursue this matter and try to rein in the FDA's overreach, we, Congress, would be responsible for the next 100 deaths from compounded medication. This example is just one of many that I have experienced with this administration.

Recently, HHS instituted a rule that would require pharmacy benefit managers to update their maximum allowable cost list every 7 days. These MAC lists control what pharmacists are reimbursed. If they are not updated regularly, pharmacists lose business because they are not reimbursed by Medicare at the present market price.

A recent call with the inspector general of HHS informed my office that pharmacy benefit managers are not complying with this new rule because HHS has not designated anyone to ensure that pricing lists are updated every 7 days.

Mr. Speaker, let me rephrase that. HHS is not enforcing their rules on MAC price updating because no one is assigned to enforce this law. You would think that, if a rule was created, the agency would work to enforce that rule, but apparently not.

Over the last 7\1/2\ years, President Obama's administration has shown a complete disregard for Article I of our Constitution and the powers that our Founding Fathers wanted this institution to have.

They interpret enacted legislation against the intent of Congress, they refuse to enforce laws that were meant to bring transparency to the American people, and they choose when congressional direction is applicable law and when it is not.

This body should take a long, hard look at the actions of these agencies. They are not following the law and intent that was created by this body, and action should be taken to remove these bureaucrats so the American people can have the government they deserve.

Again I want to thank the gentleman, Representative Yoho, for bringing this to light. This is a very serious subject that needs to be addressed.

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