One of the biggest of 2015 Medical companies focused on pharmaceutical companies, who criticized criticism from doctors, hospitals, insurance companies, and patients by purchasing their rights to prescription drugs and increasing their prices. Last week, the Senate Special Committee on Aging held the first of several hearings as part of an investigation into price increases.
One company in Congress’ cross-hairs is Turing Pharmaceuticals AG, which bought US rights to the anti-parasitic drug Deraprim and raised its price from $ 13.50 to $ 750 for a pill. Daraprim fights a parasitic infection called toxoplasmosis that afflicts HIV patients, pregnant women and others with weakened immunity. Although infection is rare, treatment is expensive because the drug must be taken for weeks or months.
A company has taken an innovative step to break Turing’s monopoly over Darpream. In December, pharmacy-benefit manager Express Scripps Holding Company announced a deal with San Diego-based Impremis Pharmaceuticals Inc. to provide a new version of the drug to beneficiaries for a $ 1 capsule. Imprimis is a compound laboratory, a specialized pharmaceutical firm that blends ingredients and makes customized medicines. In the case of Daraprim, the components are pyramidamine and leucovorin, both FDA approved generics.
Most compounders provide specialized medicines to patients who otherwise could not have received them. But there have also been accidents. In 2014, a drug made by New England Compounding Center In 20 states meningitis was associated with outbreaks, in which 751 patients became ill and 64 died. The Justice Department has charged two pharmacists with 25 murders and others were charged with multiple criminal acts, as they allegedly “knew they were producing their medication in an unsafe manner.” Under uncertain circumstances. “
Such episodes are rare in drug manufacturing, however. US News spoke to Imprimis founder and CEO Mark Bom about the unique and expanding role of drug compounders in the medical marketplace, and how pharmaceutical companies can help reduce the high cost of certain drugs. The interview was edited for brevity and clarity.
What is the role of compounding in the pharmaceutical industry?
The compound pharmacies were the original pharmaceutical companies. Compounding existed before Merck & Co. and before Pfizer. Compounding existed before [U.S. Food and Drug Administration]. Prior to 1962, the FDA was in the security business. Following the thalidomide tragedy, the FDA’s mandate for new drugs was expanded to include efficacy. The role of compounding became smaller as national and international pharmaceutical companies became larger. The FDA began to play a larger role in drug inspection and regulation. Eventually, compounding became a bespoke-medicine industry, [making customized formulations of FDA-approved drugs].
Are these drugs widely used?
If you go to almost every hospital in the United States, they all use mixed drugs. You go to any ophthalmology practice, any urology practice or any dermatology practice, they are all using mixed drugs – every single day. The idea that compounding is some type of fringe industry is absurd. It is an integral part of our pharmaceutical economy.
Can you give some examples of drugs made by compounds?
The typical compounder prepares many different drugs. Women who need them make customized doses of hormones. Children who require antibiotics are prescribed a dose that the child is able to take, such as fluids or suspensions. If a drug is made from a dye that someone is allergic to, they will make the medicine without the dye. It is truly personalized medicine.
Where does the imprimis fit in this picture?
We are a national company. We make formulations in all 50 states and we have procedures to produce large quantities for sterile and nonstyle drugs.
Federal Drug Quality and Safety Act of 2013 [which amended the Federal Food Drug and Cosmetic Act to include compounding] Divided into compounds [these] Two different regions. One includes traditional compounding pharmacies, which make different medicines for different people.
The second is more commercially scalable [to create formulations for mass distribution]. Which are called outsourcing facilities. We operate facilities for individual patients and we are building two outsourcing facilities.
How was the partnership with Express Scripts?
Philosophically, Express Scripts focuses on accessibility as a business. Accessibility has a lot to do with economics, especially today, when you have [so many] High-deductible pharmacy benefit plans. before [Affordable Care Act] It would be appropriate to have a pharmacy plan with a $ 500 or $ 1,000 annual deduction. Today, it is normal for people to deduct $ 3,000, $ 4,000, or even $ 5,000. This means they are taking thousands of dollars out of pocket every year.
In addition, Express Scripts is in a highly competitive market. They need to find cost savings for their plan sponsors. An oral medication such as Daraprim with a very low risk profile was an easy opportunity.
Did they contact you or did you contact them?
They contacted us. I was actually in New York. He said, “Hey we want you to visit our St. Louis campus.” we did. We are working with them, and it is a really good relationship.
Are you now selling this compound to patients? Are doctors writing prescriptions?
We are filling prescriptions every day.
Can you share a number
No, we are a public company, and I cannot give you any non-republican information. But I think you will see a significant percentage of Darprime scrap [Express Scripts] And, clearly, other than [pharmacy-benefit managers]. I think you other PBMs will adopt this solution.
Do people have reservations about taking drugs made by a compounder instead of a traditional manufacturer?
We issued a press release because people were concerned about quality. I have tried to make it very clear – and this is a fact – that the FDA, not to mention the state authorities, are all on our drug supply chain. We are not making these drugs behind a Chinese restaurant. We are working in a clean room environment, ranging from our raw materials to our records, on which we leave our office after leaving medicine.
The compound has been used primarily for tailor-made drugs for individual patients. Will that change?
Compounding can also address these commercial scale solutions. The problem is that the FDA does not review compound drugs, although they regulate manufacturing processes. We cannot become a viable commercial-scale solution unless the FDA regulates compound drugs.
They have found an office for branded medicines, for generic medicines and for over-the-counter medicines. But he has no office for mixed drugs. This is what is unique about my situation. I want FDA inspection, I want FDA regulation. I think this is the best thing for the long term health of our industry. It is the best for patients and it is the best for our customers.
… They now have a law, the Drug Quality and Security Act, which allows them to regulate compounding, but they are afraid to touch it because they were too screwed up in the New England compounding tragedy.
This is definitely a business-scale solution. I do not think this is a complete solution to the drug price crisis, but it is an adequate solution.
Is Express Scripps Difficult to Meet Drug Demand?
This is an easy dose. We do thousands and thousands of tips every day [more] Complex drugs; This is a walk in the park for us. It is not complicated and it is not sterile.
Some suggest that the best solution for the FDA may be for fast-track orphan generic drugs – single drugs for which there is no competitive alternative – so that they can be approved more quickly. What do you think about that solution?
Fast-tracking generic approvals are a good idea if they can do so. I’d be surprised if they were able to add that flexibility. But we’ll see.