The Commonwealth has prepared some ready-made reports broken out by manufacturer, physician and hospitals.
I question the veracity of these data as it I am sure that all manufacturers have not worked out all of the kinks of this new reporting requirement but the reports give one a good snapshot. It will be interesting to see how, not if but how, this mandatory reporting system affects the manufacturer/ physician consulting agreements and budgets that we negotiate regularly.
Massachusetts has a helpful “FAQ” page to address the issue of pharmaceutical and biotech companies interactions with health care professionals in Massachusetts. The Code itself is called Pharmaceutical and Medical Device Manufacturer Code of Conduct or “Massachusetts Marketing Code of Conduct”, Chapter 111N.
The website explains that the burden for reporting is on us in the industry (those who make any such payments):
“Manufacturers of pharmaceuticals and medical devices are required to disclose certain transactions (any fee, payment, subsidy or other economic benefit with a value of at least $50) with anyone who prescribes, dispenses or purchases prescription drugs or medical devices in the Commonwealth”
The goal of the Code is to protect patients and lower costs in the Commonwealth and limit sales and marketing activities between industry and health care providers by creating transparency of financial dealings. It seems as though the Commonwealth is betting that, if the details of payments to health care providers are public, fewer such payments will be made and therefore doctors and other HCP’s will be less influenced to prescribe certain drugs or recommend the latest-and-greatest unnecessary test.
The law itself can be read in its entirety here.
Today’s WSJ ran an article on the ongoing DOJ and SEC investigations of US drug makers suspected of paying bribes overseas to boost drug sales. Such investigations demonstrate the government’s commitment to investigating US companies for potential violations of the FCPA.
Adding a “Conflict of Interest” statement such as the one below to your Ex-US clinical agreements provides a first-line of defense against any allegations of unethical conduct which might lead to an investigation.
Conflict of Interest. Neither Institution, the Principal Investigator nor any other person who assists in performing the Study is subject to any conflicting obligations or has any financial or other interest in the outcome of the Study or has entered into any contract with respect to the Study that might interfere with the performance of the Study or that might impair the acceptance of the resulting data by the FDA, other competent regulatory authorities, or create a conflict of interest.
Further protection can be added by including a “Compliance” statement, an example of which is below.
Compliance. Institution and the Principal Investigator have been selected to conduct the Study because of their experience, expertise and resources and not, in any way, as an inducement to, or in return for, past, present or future prescribing, purchasing, recommending, using, obtaining preferential formulary status for or dispensing any Sponsor product.
The above provisions are explicit statements which serve to demonstrate one’s commitment to adhere to US laws on overseas trials. Contact us for a full list of suggested provisions in Ex-US agreements.
We have had an uptick in requests HIPAA / HITECH data protection provisions in our contracts so I thought I’d pass along a few resources we use for guidance.
Amazon has published a white paper titled, “Creating HIPAA-compliant Medical Data Applications with AWS” which can be found on aws.amazon.com (updated August 23, 2010). We have also familiarized ourselves with National Institute Standard Technologies (NIST) standards for encryption.
There is no set “number” for data encryption; “technically feasible” is the standard for level of encryption according to NIST. The old regulations mandated a 128-bit key data encryption but the new regs now leave the level of encryption to the judgment of the individual entity managing said data.
Treating physicians use PET scans to evaluate whether or not a patient with a newly-discovered or suspected solid tumors are candidates for an invasive diagnostic or therapeutic procedure. Most solid tumor clinical trials require an initial PET scan as part of the screening process to qualify study subjects for clinical studies and many sponsors mandate more than one PET scan in the course of treatment. Oftentimes, the sponsor must compensate the clinical sites for subsequent PET scans as most study budgets are created to conform to the National Coverage Decision (NCD) guidelines. It should be noted that PET scans provide essential data for evaluation of and treatment of solid tumors and, as a matter of course, the FDA will require numerous PET scans for a solid tumor clinical study.
CMS has now revised Section 220.6.17 of the NCD to expand the number of PET scans covered if the treating physician determines that additional PET scans are required to ensure proper medical care. Now local Medicare administrators will have the flexibility to determine what the standard of care for number of PET scans will be in their respective regions. Of course, as local administrators vary in their standards, the removal of this restriction will not ensure that each and every Medicare administrator will expand PET scan coverage but it certainly will lessen the impact that numerous PET scans have on our clinical study budgets.
More good buzz for Synta! E-zine Xconomy (right next door to another valued client, Molecular Insight here in Cambridge) posted a piece on Synta’s rise-fall-rise again story.
I enjoy reading any positive story about our Massachusetts Life Sciences community but it is always a plus when a client is the subject; I feel as if we share in the success.
That is the question that Senator Chuck Grassley has posed to 16 pharmaceutical companies regarding their treatment of employee whistleblowers who file under the False Claims Act
The False Claims Act, also known as “Lincoln’s Law”, provides a pathway for private citizens to sue on behalf of the government and share in any recovery.
The Act is called “Lincoln’s Law” as President Lincoln supported and enacted the law in an effort to crack down on post-Civil War carpetbaggers who filed false claims with the US government for funds that were intended to rebuild the South. The law remained dormant for over a century until the mid-80s when Congress re-enacted it to recover funds and prevent those infamous claims for $800 toilet seats at the Pentagon.
Today, whistleblowers whose information leads to a government investigation and recovery eventually share in the recovery. Justice Department records show that whistleblowers who filed under the False Claims Act were paid $2.39 billion from 1987 to 2009.
We are interested in the findings of Sen. Grassley’s fact-finding mission as the concern is that potential whistleblowers’s fears of retaliation may impede future Justice Department investigations and recoveries. So many US companies are towing the line and have implemented stringent in-house compliance programs that we need those “bad apples” separated from the bunch to prevent us all being cast in a negative light. We’ll post the findings as soon as they are published.
I have been enjoying this online magazine for a few weeks now and thought I’d share the link with our clients. Although the site has a dedicated “Life Sciences” page, its coverage of all Massachusetts-based business current events make it a one-stop site for tax news, financing trends and our daily ups-and-downs here in the Commonwealth.
Check it out!
The FDA has released a hold on EMD Serono’s STIMUVAX clinical program. EMD Serono, a valued client of Contracts Associates, is set to resume thePhase III START and INSPIRE clinical studies; both of which provide alternatives to those families in search of treatment options for NCSLC.
Both studies were suspended following a serious unexpected adverse events in a study subject on one of its Phase II STIMUVAX stidues. Full details can be found on EMD’s website.
Our long-time client Synta and its CEO Safi Bahcall are the subjects of a recent Malcolm Gladwell article in the New Yorker. The article can be found here. It is an interesting read and sheds light on the internal ups-and-downs so many in our industry are facing. Overall, the article has a very positive message and I for one enjoyed the behind the scenes glimpse of the decision making processes that make or break upstarts like Synta. The article is great PR for Synta and a welcome change from the “vanilla” profiles we usually see on large pharma companies.
Contracts Associates Inc.