Life Science Compliance Update

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33 posts from October 2016

October 31, 2016

Open Payments Having an Adverse Effect on Physician-Rep Relationships


Open Payments, a program created by the Physician Payments Sunshine Act (part of the Affordable Care Act) has started to come between drug representatives and physicians. For quite some time, physicians and pharmaceutical reps have had a warm relationship, with the latter coming to the offices of the former, bringing food, small gifts (i.e., pens), and educational material.

The relationships between reps and physicians started to come under scrutiny prior to the first release of Open Payments data, which keeps track of payments drug and device companies make to physicians and teaching hospitals for things like travel, research, gifts, speaking fees, and meals. The data also includes ownership interests held by physicians or their immediate family members in drug and device companies.

Since the release of Open Payments data, many studies have been done, purporting to show a negative link between the relationships pharma and physicians have. Myriad negative press followed those studies, making doctors and pharma out to be bad people for their interactions. We have written many times on the subject, including why we feel as though the relationships between doctors and pharma can actually be beneficial.

Now, however, it seems as though the bad press the relationships received is starting to have an effect. According to a new survey by SK&A, the percentage of physicians who do not allow access to medical industry salespeople has grown to 36.5% in 2016, up from just 22.9% in 2010.

Interestingly, for physicians employed by hospitals and health systems, the no-access rate tops 50%. This may be in part because physicians working for such employers tend to not make their own rules on seeing drug reps, the employers do.

Site ownership

The study also found that the ability of drug reps to get inside a physician’s office varies considerably by region. The no-access rate is highest in the West and lowest in the South. The state with the highest rate of physicians not granting access to drug reps is Vermont, with 63.7%, while the lowest state is Mississippi, with only 24.6% of its physicians denying access to drug reps.


The survey did find one trend that seems to run counter to the rest of the results, however: as the no-access rates increase, the requirement for appointments seems to be trending downward. The percentage of those who don’t require, or prefer, an appointment with a rep has fallen, from 49.8% in 2010 to 35.2% in 2016.

Such high rates of no-access may not be the best thing for the health care industry as a whole. While we do not think that physicians should look to pharma for lavish dinners out or speaking fees at events that don’t exist, we do believe that physicians should not feel like they are being blacklisted because a rep comes to visit their office and brings Papa Johns for the office. Such visits from drug and device reps can be beneficial to doctors and their staff, as it provides a time for them to ask questions of the rep to see if the offered device or prescription is a good fit for any of their patients.

Helping the Patient - Co-Pay Reimbursement Can Be Okay in Certain Circumstances


The OIG’s recent Advisory Opinion suggest that under certain circumstances patient co-pay reimbursement programs are allowable. This article examines that opinion and highlights the types of controls that are likely needed.

Pharmaceutical companies have struggled with product messaging for years. With more and more healthcare professionals (HCPs) becoming “no see” HCPs, the companies have turned to the ultimate consumer of their product – patients. At the same time, insurers are asking patients directly to shoulder more of the healthcare costs by raising their co-pays and deductibles.

Read Full Article in the October 2016 Issue of Life Science Compliance Update

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October 28, 2016

California to Allow Experimental Drug Treatments for Terminally Ill Patients


California Governor Jerry Brown recently signed legislation allowing terminally ill patients in his state to have access to experimental drugs that have not yet been approved by the United States Food and Drug Administration (“FDA”). This recent stamp of approval stands in stark contrast to his veto last year of a similar bill, then saying that the FDA already has a program in place to allow for the use of experimental drugs and that he wanted to see whether changes in the FDA’s Compassionate Use program would reduce the minimum thirty-day waiting period for experimental drugs.

While the FDA did streamline the process by which patients can apply for expanded access or compassionate use to obtain experimental drugs, the new California law goes even further, allowing patients to entirely circumvent the FDA.

Under the legislation, patients must meet a variety of requirements to qualify for the program, including a requirement that they have only a matter of months to live and that two doctors recommend they try the experimental drug. Additionally, drug makers and device manufacturers would not be required to accommodate a patient’s request for experimental products. It also provides protection for insurers, limiting their liability for outstanding debt related to the treatment if the patient dies.

This legislation is significant, in part because it follows a path that voters in California started twenty years ago: back in 1996, California voters passed Proposition 215 to legalize medical marijuana. According to California Assemblyman Ian Calderon, author of the bill, “terminally ill patients in our state will finally have access to potentially life-saving treatments.”

Around the United States

Right to try legislation has been enacted in thirty-one other states, including Arizona, Colorado, Connecticut, Florida, Georgia, Louisiana, North Carolina, South Carolina, Virginia, and Wyoming, crossing political parties and regional differences. New Mexico is the only state that has not seen a right to try bill introduced. The primary driver behind these laws has been the Goldwater Institute, which offers model legislation to states and their legislators. The model legislation serves as the basis for laws that have been passed in most states.

Tension in the Industry

Though California is the thirty-second state in the United States to enact such legislation, there is still a vocal and tense argument between two camps within the healthcare industry: those who support such legislation, and those who oppose it.


Those who oppose such legislation, including oncologists and medical ethicists, believe that access to experimental drugs offers false hope to those with life-threatening illnesses and that experimental drugs have only a limited change of actually working and that pharmaceutical companies have no obligation to offer drugs that are still working their way through trials.

Opposition also notes that Right to Try laws “permit access to experimental drugs after they have passed only Phase 1 trials. At this point in drug development, there is scant evidence about basic safety of the new substance and virtually no data that proves its efficacy in treating the targeted disease. Yet the right to try movement suggests that these early interventions are a magic pill, and that cures are being withheld from dying people solely because of government red-tape or for financial reasons. Even if there were such impediments, the implication that a drug that passes Phase 1 is a cure — and a cure that would not pose substantial risk of pain, injury, or earlier death — is unsupportable.”


Proponents of right to try legislation believe that such laws provide options to patients who cannot wait for drugs to make their way through the FDA’s arduous approval process. According to, “Right to Try Laws give people with terminal illnesses the legal right to use investigational medications years before they might otherwise be on the market. No one can guarantee that a particular treatment will be effective, but these laws return choice and control over treatment options to where it is most effective: with patients and their doctors.”


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