Life Science Compliance Update

February 20, 2018

12th International Pharmaceutical and Medical Device Compliance Congress

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This May, the 12th International Pharmaceutical and Medical Device Compliance Congress will take place in Vienna, Austria, at the Hotel Savoyen, from the 14th through the 16th.

Keynote speakers for this conference include: Nicola Bedlington, Secretary General, European Patients Forum (EPF), Former Director, European Disability Forum, Brussels, Belgium; Jan Oliver Huber, General Secretary, Association of the Austrian Pharmaceutical Industry (PHARMIG), Vienna, Austria; Camilla de Silva, Joint Head of Bribery and Corruption, Serious Fraud Office, London, UK; and George “Ren” McEachern, CFE, CAMS, Managing Director, Exiger, Former Supervisory Special Agent, International Corruption Squad, US Federal Bureau of Investigation, Washington, D.C.

Co-Chairs of the event include: Dante Beccaria (Sanofi, Paris, France); Stephen Nguyn Duc (Rungis, France); Suzanne Durdevic, LLM (Boston Scientific International, Paris, France); Dominique Laymand, Esq. (Ipsen, Paris, France); and Roeland Van Aelst (Johnson & Johnson, Brussels, Belgium).

The event was just announced on February 8, 2018, and a call for proposals has been sent out. If you are interested in submitting a proposal, you may do so here.

To register for this conference, click here, or call (800) 503-8171. Standard conference registration is €1,795 (est. $2,198.05) through March 16, 2018; €1,995 (est. $2,442.96) through Friday, April 13, 2018; and €2,195 (est. $2,687.87) after Friday, April 13, 2018.

February 09, 2018

New PhRMA Website Tackles Pharmaceutical Cost and Coverage

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On January 24, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) launched a new website, LetsTalkAboutCost.org. The new website aims to provide consumers with easily understood information about the cost and coverage of medicines.

The website utilizes an interactive quiz format to educate consumers about medicine spending and pricing trends, insurance coverage of medicines, the biopharmaceutical supply chain, the role of hospital markups and other health care cost issues.

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The website asks questions such as “Who decides what I pay for my medicine?” and then answers them directly after. For example, the answer to that question is listed as “While biopharmaceutical companies set the list price for a brand medicine, more than one-third is rebated back to payers and the supply chain. Insurers negotiate large rebates, but do not share these discounts with patients who pay a deductible or coinsurance -- a percentage of costs a patient is responsible for paying out of pocket -- for their medicine. Ultimately your insurer determines what you pay for your medicine out of pocket.”

The website also includes a blog with topics like how private-sector collaboration can lead to cost savings and care improvement and links to some of the various ads and resources PhRMA has compiled on the topic of prescription drug costs.

It is an informative and helpful website and one can only hope that patients and caretakers take the time to review the website and educate themselves on the topic to discern fact from fiction on the hot topic of drug pricing.

February 01, 2018

State of the Union De-Briefing

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President Donald Trump gave his second State of the Union address this week, and while reactions to his speech were mixed, he mentioned several items of importance to the healthcare space.

Affordable Care Act

First, he noted the repeal of the individual mandate found in the Affordable Care Act, by noting, “We eliminated an especially cruel tax that fell mostly on Americans making less than $50,000 a year -- forcing them to pay tremendous penalties simply because they could not afford government-ordered health plans. We repealed the core of disastrous Obamacare -- the individual mandate is now gone.”

Interestingly to some of his most ardent fans, however, the President did not call for the repeal of the Affordable Care Act in its entirety. Therefore, it seems as though his focus on the ACA will be muted with respect to the rest of the ACA that is still in place, including the Medicaid expansion and other reforms.

Right to Try

President Trump also noted his belief in right to try laws, stating, “We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives. People who are terminally ill should not have to go from country to country to seek a cure -- I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’”

Vice President Mike Pence has long held Right to Try as a priority of his, and Trump’s call on Congress to pass legislation comes amid stalled House legislation, which easily passed the Senate in August.

More than half of the states have laws that already exist to allow some patients access to experimental treatments and the Food and Drug Administration also hash a pathway that grants expedited access to treatment to patients with terminal illnesses; however, FDA Commissioner Scott Gottlieb has been reluctant to expand much past that.

Opioid Abuse

Many Senators and Congresspeople wore purple ribbons in an attempt to highlight the opioid crisis. President Trump addressed this hot-button issue as well, saying, “In 2016, we lost 64,000 Americans to drug overdoses: 174 deaths per day. Seven per hour. We must get much tougher on drug dealers and pushers if we are going to succeed in stopping this scourge. My Administration is committed to fighting the drug epidemic and helping get treatment for those in need.”

As we have previously written, President Trump has always placed a priority on resolving opioid abuse, including creating a Task Force to review the situation and craft a plan of action. However, he has yet to propose new funding to help states respond (one of the suggestions we often hear from Democrats).

Newly appointed Health and Human Services Alex Azar recently highlighted the administration’s five-point strategy, including (1) encompassing better treatment, prevention, and recovery services; (2) better targeting of overdose-reversing drugs; (3) better data on the epidemic; (4) better research on pain and addiction, and (5) better pain management. Funding for treatment will continue to be central to the debate, and it remains to be seen whether Congress will provide the boost that many public health advocates have been calling for.  

Drug Pricing

Prescription drug prices were a hot topic in the 2016 Presidential election and were, naturally, mentioned during the State of the Union as well. President Trump stated, “To speed access to breakthrough cures and affordable generic drugs, last year the FDA approved more new and generic drugs and medical devices than ever before in our history... One of my greatest priorities is to reduce the price of prescription drugs. In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my Administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”

Given the political climate, little action has been seen on this front while excessive rhetoric continues to be the modus operandi of the political class.

Conclusion

Overall, there were statements by the President that earned cheers and some jeers from both sides of the political aisle. While lip service can be effective in providing a motivating speech, we will have to wait to see what changes are actually effectuated in the future.

 

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