Pharmaspective

Data Mining Before the Supreme Court Today

In 2007, Vermont enacted a law to restrict how a doctor’s prescribing data  may be used, specifically placing limits on the use of such data for marketing purposes.  IMS Health Inc., a company that sells the prescribing information to pharmaceutical industry clients, joined  with PhRMA and others,  to challenge the Vermont law in federal district court claiming that it violated their right to free speech.  The federal court upheld the law, but an appellate court reversed that decision (in conflict with rulings in Maine and New Hampshire that upheld similar laws in those states).

Today, the Supreme Court will hear oral arguments in Sorrell v. IMS Health Inc., et al., the case brought before the Court by Vermont’s attorney general, William H. Sorrell, that tests whether Vermont’s law violates the free-speech protection of the First Amendment.  Industry and regulators alike will be watching closely for the outcome of this case, which could have a significant impact on the future of pharmaceutical sales and marketing practices.  In recent years, the Court has shown an interest in protecting companies’ commercial free speech rights.  Which way do you think the Court will go in this case? 

Bad Ads, Beware!

With the debut of FDA's Bad Ad Program in May 2010, FDA looked to healthcare providers to become a new offensive against misleading prescription drug promotion.  Simultaneous to the launch of the Bad Ad Program, a Reuter's Article reported the intent of the Bad Ad Program was to “increase regulators reach into the largest area of prescription drug promotion – the private contacts between drug company sales people and prescribers.” 

 Yet, nearly one year since the launch of the program, DDMAC has issued only two Warning Letters resulting from complaints to the Bad Ad program: first, to Hill Dermaceuticals, Inc., for its website for Derma-Smoothe/FS® in December 2010 and, recently, to Three Rivers Pharmaceuticals, LLC, dated March 21, 2011, for its STATgram promotional material for Infergen®.   Neither Warning Letter specifically referenced any private interactions between the sales representative and the prescriber as the genesis for the investigation and ultimate issuance of a Warning Letter by DDMAC.   Instead, both letters resulted from seemingly traditional promotional activities.  In the case of the Warning Letter issued to Three Rivers Pharmaceuticals, LLC, the STATgram had been provided to DDMAC under cover of Form FDA 2253.

On the heels of its recent Warning Letter resulting from a complaint from the Bad Ad Program, DDMAC will be presenting a webinar titled, "An Overview of FDA's Bad Ad Program," on April 28, 2011, at 12:00 p.m. (ET).”  The announcement on FDA’s website indicates this webinar is one in a “series of educational webinars, developed by FDA pharmacists and targeted to the needs of all healthcare professionals and students.” 

Has FDA shifted its focus of the Bad Ad program from the private interactions between sales representatives and prescribers to get healthcare professionals to report on more general promotional activities and materials?  Is it fair for the FDA to use healthcare professionals  to police industry’s promotional activities?  Should we expect to see a rise in Bad Ad complaints? 

UK Leaps Ahead of US and Issues Informal Guidance on Digital Communication

FDA recently announced yet another delay in the release of its first draft guidance to pharmaceutical companies regarding the use of social media.  In the meantime, the UK regulator, Prescription Medicines Code of Practice Authority (“PMCPA”) released an informal guidance on digital communication.   Rather than develop new rules, the PMCPA issued an 11 page Q&A document that points to specific clauses in the ABPI Code of Practice for the Pharmaceutical Industry that apply to all communications, including digital communication.  The guidance poses 12 questions related to the use of digital communication, such as the use of search engine optimization, blogs,  and Wikipedia, and provides simple, direct responses.

 Click here is a link to view a pdf of the PMCPA Q&A document.

Does this informal Q&A provide UK pharmaceutical companies with sufficient  guidance regarding the permissible use of digital communication?  Will the FDA follow PMCPA’s lead and issue an informal guidance on social media and digital communication that relies on existing promotional guidelines and regulations?   Would the US pharmaceutical industry benefit from an informal Q&A guidance on the use of social media rather than the issuance of specific regulations? 

Possible Consequences of a Government Shutdown – Could it Impact Patient Access to Prescription Medications?

By:  Anne E. Wagstaff

As tomorrow’s midnight deadline approaches, it appears more and more likely that Congress will be unable to agree on the 2011 budget before the federal government is forced to shut down. One of the many unintended and lesser known consequences of a lengthy government shutdown is the potentially devastating impact a delay in Medicare and Medicaid payments could have on our country’s pharmacies.

During a government shutdown, the federal government still provides essential services. As a result many of the nation’s health-related services will continue during this time. For instance, the National Institute of Health’s ongoing clinical studies will continue, although no new studies will begin. VA hospitals will keep their doors open, since the majority of their funding was previously awarded in advance appropriations in a two-year budget cycle. Medicare will pay doctors and hospitals from its trust funds. However, these payments could be delayed in the event the shutdown continues for several months, and it is this delay that poses a serious threat to pharmacies.

In the current healthcare environment, pharmacies receive a significant portion of their money from the federal programs, Medicare and Medicaid. In many cases, pharmacies depend upon these government payments to pay their suppliers and wholesalers. Todd Evers, BPharm, President-elect of the Illinois Pharmacists Association explained to the American Pharmacists Association that “unlike other medical providers, pharmacy must pay for products, not just services, and these bills are due weekly or biweekly.” According to Mr. Evers, state Medicaid programs, which receive matching federal dollars, often take at least 7 to 14 days to provide payments to pharmacies. Some states take much longer.

A brief government shutdown may be manageable; but if payments from the federal government to the states are delayed, and the states delay their payments to the pharmacies, it could impact the ability of some pharmacies to make required payments to their wholesalers. Although a shutdown might not have a significant impact on the large retail pharmacy chains, smaller pharmacies or pharmacies located in rural areas might be forced to ask patients to pay in cash or even close their doors.

Who Knew Drugs Could be the Answer to the Federal Deficit?

 
In a prior post, “Will the ‘New Normal’ Affect the Life Sciences Industry," we queried whether the life sciences industry would become a target during the on-going government budgetary crisis.  President Obama’s recently released Budget of the United States Government for Fiscal Year 2012 includes provisions targeting the Department of Health and Human Services, some of which will likely impact the life sciences industry.

Two of the budgetary proposals intend to bring generic versions of brand-name drugs to market sooner than originally permitted, reducing federal healthcare costs. Specifically, the 2012 Budget includes proposals to modify the period of data exclusivity for brand name biologics from 12 years to 7 years, expediting the availability of data formulas for brand-name biologics by 5 years, and essentially shaving off 5 years of expected profits for the originating company. Additionally, the Federal Trade Commission would be authorized to prohibit drug companies from entering into anti-competitive agreements extending the period of exclusivity for brand name drugs. By reducing the exclusivity time of biologics and potentially prohibiting the ability to extend the exclusivity of other generics through private agreements, these two budgetary proposals estimate a reduction of the federal deficit by approximately $11M. From the perspective of the life sciences industry, this projected reduction to the federal deficit may prove to be an insubstantial figure compared to the potentially significant profits that pharmaceutical companies may forfeit, not to mention the potential freezing effect these proposals may have on innovations from pharmaceutical companies in the coming years.

Not all of the budget proposals will advance, but we do expect that life science companies will feel some pain.