Illustration of a robber wearing a mask runs off with a bag of money

Patient Advocacy Groups – Pharma in Disguise?

By Phebe Hong

The mission of the Patient Access Network Foundation (PANF) is “[t]o help underinsured people with life-threatening, chronic and rare diseases get the medications and treatments they need by assisting with their out-of-pocket costs and advocating for improved access and affordability.” PANF proudly boasts that since 2004, it has “provided nearly 1 million underinsured patients with over $3 billion in financial assistance, through close to 70 disease-specific programs.”

Despite its altruistic mission statement, PANF recently found itself in hot water. On October 24th, PANF agreed to a $4 million settlement with the Department of Justice over allegations that the group paid kickbacks to Medicare patients purchasing specific medications. In parallel, another patient group called Good Days settled for $2 million with the DOJ over similar allegations.

Read More

Screenshot of HHS secretary Alex Azar speaking on television

Hits and misses from the Senate HELP Committee hearing on the President’s Blueprint for lower drug prices

By James Love

 

The Senate HELP committee held a hearing on June 12 on “The Cost of Prescription Drugs: Examining the President’s Blueprint ‘American Patients First’ to Lower Drug Prices” where Secretary Alex Azar was the sole witness.

It was a moment for the Democrats in the Senate to draw a sharp contrast with the Trump Administration on an issue voters care about: drug prices.

Read More

Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Read More

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Read More

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Read More

New Drug Pricing Bill from Democrats Balances Innovation, Access

By Rachel Sachs

Yesterday, a group of 20 Democrats in both the House and Senate introduced the Improving Access to Affordable Prescription Drugs Act, a 129-page bill designed to lower drug costs while increasing innovation and promoting transparency.  The bill aims to accomplish a number of different goals, and in this post I’ll go through the different functions it serves and consider some notable provisions.  For those who are interested, here’s a provision-by-provision summary.  This is going to be a very long post, so I apologize in advance.

On the whole, I think there’s a lot to like in this bill, particularly in its promotion of innovation and in the way in which it seeks to curtail bad actors within the industry.  However, I don’t agree with all of its provisions (as you’ll see) and I view some of its proposals as kludge-y solutions to kludge-y problems our complex system has created.  I’m not yet sure whether I see that as a bad thing, to be clear – it works to create meaningful change within a system that was cobbled together over decades, mostly accidentally.  But it isn’t the platonic ideal of a value-based pricing system, or anything similar.

Read More

Genetic counselors, genetic interpreters, and conflicting interests

By Katie Stoll, Amanda Mackison, Megan Allyse, and Marsha Michie

The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” to clinicians, and providing direct patient care. Although the communication skills and genetics expertise of the genetic counselor prepare them well for these roles, they also raise concerns about conflicts of interest (COI).

Why are genetic counselors leaving clinics and hospitals for industry jobs? Alongside greater job flexibility and taking on new challenges, a big reason is better pay. Hospitals and clinics have difficulty competing with the higher salaries at commercial labs because of continuing challenges in insurance reimbursement. Apart from limited preventive care covered under the Affordable Care Act, genetic counseling is inconsistently covered by private payers. Medicaid reimbursement for genetic counseling is state-dependent, and Medicare does not recognize genetic counselors as reimbursable health care providers at all.

Genetic counselors’ primary objective has historically been to help patients navigate difficult medical genetic information and decisions, supporting their autonomy.  But as laboratory employees, they must also navigate their employer’s financial interests, including increasing the uptake of genetic testing. In this changing landscape, can the profession of genetic counseling maintain the bioethical principles of beneficence, informed consent, and respect for autonomy that have been its foundation and ethos? Read More

Sarepta: Where Do We Go From Here?

By Rachel Sachs

This morning, the FDA finally reached a decision in the closely watched case of Sarepta Therapeutics and its drug for the treatment of Duchenne Muscular Dystrophy (DMD).  The FDA granted accelerated approval to Sarepta’s drug, Exondys, on the condition that Sarepta complete a new trial demonstrating the drug’s clinical effectiveness.  As regular FDA observers already know, Exondys’ path to approval has been highly contentious.  The key clinical trial used to support approval contained just twelve patients and no placebo, and the FDA Advisory Committee voted against both full approval of the drug and accelerated approval.  The FDA’s 126-page Summary Review, released today with their approval letter, reveals the intense disagreements within the agency over Exondys’ approval.  FDA staff scientists charged with reviewing the drug recommended against approval but were overruled by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research.  FDA Commissioner Califf deferred to her decision.

Sarepta presented the FDA with a series of bad options.  DMD is a rare, heartbreaking, and ultimately fatal genetic disease with no other real treatments, and it is clear why patients and their families would fight for access to anything that might work.  At the same time, the FDA has rarely if ever approved a drug on less evidence than that provided by Sarepta, and approving the drug might send a dangerous signal to both the public and other companies investigating rare disease drugs.  The FDA has now made its choice.  Where do we go from here?  In my view, there are at least three key issues to watch going forward. Read More

Drug Pricing, Shame, and Shortages

By Nicholson Price

Drug prices have been making waves in the news recently.  The most recent case is the huge price hikes of the EpiPen, which provides potentially life-saving automatic epinephrine injections to those with severe allergies.  Mylan, which makes the EpiPen, has raised its price some 450% over the last several years.  The EpiPen is a particularly problematic—and media-friendly—story because the emblematic use case is the kid in school who can’t breathe because she came into contact with peanuts.  Jacking up the price on something that’s not optional—for parents and for schools—seems heartless.  Thoughtful pieces have pointed out how the EpiPen price increases demonstrate problems with our health care system and drug/device approval system in general.

Other big recent cases that have hit the news include huge increases in the price of insulin, and, of course, Turing Pharmaceuticals’/Martin Shkreli’s ~5000% price hike on the drug Daraprim.  The EpiPen and Daraprim are especially notable because patents mostly aren’t involved—the effective monopoly appears to come from the delay or challenge in getting generic products approved by FDA (although the EpiPen itself also seems tough to make).  And, of course, drug prices aren’t regulated in the US the way they are in much of the world.

These stories seem crazy, cruel, and fascinating.  And they raise (for me, anyway) the question: what’s changed?  This seems like a relatively new phenomenon.  But FDA’s had a backlog for a while, and drug prices have long been unregulated. Read More