Reader TTS

Ten years ago, there might have been 30 people in New Jersey who got a stomach virus, but you would have never known that those 30 people had the exact same pathogen. Now when you have 30

people in New Jersey all infected by the same strain of _E. coli_, the exact same strain and maybe a strain of _E. coli_ in the database that we maintain has been associated with foodborne

outbreaks before, now you know that it was something they ate. Now you’re able to talk to them and find out what they ate, what is the common source, and then go to the common source and do

soil testing and other sampling to see if we can find that strain in whatever facility produced the food. To give you a real-life example of this, we did a major recall of eggs one year ago

this month. It was a North Carolina facility. We recalled tens of millions of eggs. It was a huge recall. What had happened was there was an outbreak where people were sporadically getting

sick. When we interviewed the people, we found out that they had all eaten eggs in the same restaurant chain. The entire chain sourced their eggs from one facility. We went into that

facility and took samples and found the exact same pathogen in one henhouse and in the production line.  YOU’VE FOCUSED ON THE AVAILABILITY OF BIOSIMILARS DURING YOUR TIME AS COMMISSIONER.

[BIOSIMILARS ARE THE GENERIC VERSIONS OF BIOLOGIC DRUGS, MADE FROM LIVING ORGANISMS, AND ARE PRICED LOWER THAN BRAND-NAME BIOLOGICS.] THE AFFORDABLE CARE ACT PROVIDED A PATH FOR APPROVING

BIOSIMILARS, BUT THAT MARKET HASN’T TAKEN OFF AS MUCH HERE AS IT HAS OVERSEAS. WHY ARE BIOSIMILARS SO IMPORTANT, PARTICULARLY IN THE DEBATE OVER LOWERING PRESCRIPTION DRUG PRICES? I think

they’re important because biologics is the fastest-growing segment of drug spending. These are generally used in patients with more serious medical conditions and they can be out of pocket a

lot of money for these drugs even if they have good coverage. If a drug costs $100,000 and the patient has a 10 percent copay, they quickly maximize their entire out-of-pocket for the year.

It’s a public health concern if patients can’t have access to these medicines because they can’t afford them.  WHAT HAS TO HAPPEN FOR BIOSIMILARS TO BECOME MORE POPULAR? Health plans are

meeting a lot of resistance from physicians who don’t feel comfortable [prescribing biosimilars instead of brand-name biologics]. That’s the biggest challenge right now, but I think that

that challenge will start to resolve over time as doctors gain more comfort with these. We need to educate physicians. It’s going to be a slower process, but I don’t think it’s an

insurmountable hurdle. It’s going to happen.  The same thing happened when we created the pathway for traditional generic drugs; doctors were reluctant to use them. There was a lot of

skepticism that they weren’t the same thing. It took time to build comfort. YOU’VE CALLED OUT MANY OF THE BIGGEST PRESCRIPTION DRUG MANUFACTURERS FOR THWARTING THE DEVELOPMENT OF GENERICS.

YOU REFERRED TO THEIR TACTICS AS “SHENANIGANS.” WHAT NEEDS TO HAPPEN TO INCREASE ACCESS TO GENERICS? We make a tradeoff in society where we allow innovations to be priced high in order to

provide returns on the risk-taking and the investment, with the expectation that there will be competition down the road.  Companies were using the risk management programs that we have

promulgated as a way to thwart the ability of generic companies to get access to the doses they need in order to do the studies that they needed to run to get market approval for a generic.

They’re still doing that, but they’re doing it less now.  What I see them doing more of is using specialty pharmacy companies to tightly control who they sell the drug to. They might

distribute the drug through a single specialty pharmacy and have agreements with that specialty pharmacy that say, “You can’t sell to anyone but these entities.” They exclude the generic

company from being able to buy the drug.  So they’re moving on to different tactics in the marketplace. That doesn’t mean that we should forget the old problems, because as soon as we take

our eyes off of them, that behavior might crop up again. It does mean that we need to make sure that we are also focused on the new gaming tactics.