As of June 2010, sponsors that are obligated to pay any medical expenses for what is deemed to be a research-related injury must determine whether the subject is covered by Medicre and, if so, report its payment obligation to CMS.

The ICF clause that many sites take issue with reads:

In the event Sponsor provides any reimbursement for medical treatment, Sponsor must first comply with federal reporting requirements relating to the reimbursement of such costs, including the provision to Medicare of your Health Insurance Claim Number or, if none is available, your social security number. By signing this consent, you agree that if asked by the Study Doctor, you will provide such information to the Study Doctor for disclosure to the Sponsor.

While HIPAA allows covered entities such as a hospital to disclose PHI to meet its own legal obligations, there is no clear authority that allows disclosure to enable other entities to meet its obligations.Therefore, the disclosure of the MSP-required PHI to a sponsor must be included in each informed consent form.

The inclusion of the ICF clause above is crucial to ensure a sponsor’s ability to comply with the CMS reporting requirement. Part of our job is to educate clinical sites on contract terms that are essential to allow sponsors to fulfill their legal obligations and this term is one that we can never “cave” on.

Ideal candidate will be available 40 hours a week to work virtually with some on site work as needed. Responsibilities include managing and overseeing preparation, negotiation, and execution of day-to-day pharmaceutical corporate contracts including without limitation, US and ex-US clinical trial agreements, CRO agreements and statements of work, health care provider consulting agreements, vendor and service contracts, master agreements, laboratory services agreements, material transfer agreements, supply agreements, confidentiality or non-disclosure agreements, and related agreements. Ability to handle multiple tasks for multiple clients in a fast-paced, high volume environment is essential. Willingness to take initiative, be proactive, and good people skills are a must. Coordinate with client teams regarding contract needs and priorities. Prepare draft agreements in response to clients requests using pre-approved client templates. Manage negotiations on clients’ behalf with outside parties regarding contracts, and communicate with client attorneys and/or project managers regarding the same. Generally work to ensure clear and prompt communication with clients’ attorneys, employees, and outside vendors regarding contracts. Keep up-to-date on legal issues relating to the pharmaceutical industry and contracts for the same, and perform miscellaneous tasks and other duties as required for effective implementation, management, and upkeep of clients’ contracts and agreements. JD, 3-5 years, in-house background in pharmaceutical company required; familiarity with healthcare industry and regulatory environment preferred. Understanding of PhRMA code, FDA, OIG guidances, False Claims Act, Anti-kickback and other healthcare related statutes and regulations.

If interested, please email your resume and a cover letter to: cms@contractsassociates.com

The fee amount is fixed each year by statute, $2.5 billion for 2011, and will be allocated by the IRS among branded prescription drug manufacturers and importers based on each manufacturer’s share of the government market, from data supplied by the Centers for Medicare and Medicaid Services (CMS), VA and DOD. More information on the fee: http://www.irs.gov/irb/2010-50_IRB/ar11.html

The promotional flyer I received has the following synopsis: “(the) FDA should resist the temptation to allow cultural fears to influence regulation of GE animals; oppose calls for mandatory labeling of GE animals based solely on their GE character; refuse demands to apply the precautionary principle to regulation of GE animals; and apply nuanced ethical analysis to animal welfare issues involving GE animals.”

Really?  The founding of the predecessor of the FDA was a direct response to a cultural shift in America (influenced in part by the publication of Upton Sinclair’s “The Jungle”); a call for government oversight of food safety and truth-in-advertising for the numerous tonics being pushed by snake oil salesmen. It stands to reason that, if the government is instituting labeling guidelines for organic food and the like, there should also be labeling for GE animal products as some Americans may wish to make informed choices en shopping for their families.

I can’t see why the FDLI is sponsoring this seminar and I cannot imagine what type of professional would take time out of their day to attend it.  Why not just let the U.S. Beef and Cattle Industry sponsor their own seminars for FDA policy makers and leave the FDLI out of it? With a 2010 retail equivalent value of $74 billion, they can afford it. The Industry could probably also absorb any costs that mandatory labeling would cause them to incur but I don’t imagine that issue will be raised in this objective, unbiased seminar.

The whistleblower rules will impact not only all public pharma companies, but also all private pharma companies that do business with public companies and entities regulated by the SEC. Your private company could find itself the subject of an SEC / DOJ investigation.

We can help you adequately instruct your employees on the impact of the new Rules. Contact Colleen at cms@contractsassociates.com for information that your company needs to know.

Presently, the European Patent Office (EPO) grants patents but the inventor has to then request validation from each individual EU country in which he/it desires patent protection. The average cost to the inventor for the validation process alone is approximately 32,000 euros ($45,500 USD). In the US, patent filings typically cost less than $5,000.

The proposed “single patent” system would also eliminate many of the costly country-by country annual renewals and patent maintenance fees.

Under the Commission’s newly-presented proposals, the cost of a single EU patent in the 25 participating member states (Italy and Spain have declined so far to participate in the proposals) would be 680 euros ($1,000 USD), following a transitional period (into two agreed-upon languages) during which the costs would still be less than 2,500 euros (3,500 USD).

Current holders of European patents would be able to apply at the EPO for unitary patent protection, which would ensure the same level protection for their inventions throughout the 25 nations.

The legislation’s supporters are confident that cost-saving, streamlining of the EU system will lead to more innovation and development. At the very least, the cost-savings and simplification of protections will be a welcome change to our industry. Biotechnology patent filings increased 42.6% to 7,400 applications in 2010, and pharmaceuticals patent filing increased 20% last year for a total of 6,700 filings.

“A description of this clinical trial will be available on
http://www.Clinical Trials.gov, as required by U.S. Law. This Web site
will not include information that can identify you. At most, the Web site
will include a summary of the results. You can search this Web site at
any time.”

Call or email us if you have any questions about this amendment to 21 C.F.R. § 50.25 in particular and/or the requirements for informed consent documentation in FDA-regulated clinical trials of drugs, biological products, and medical devices in general.

Our company made a small contribution to the fund set up for him. I found the thank you letter to be especially touching and thought I’d post it here: NYC Taxi Drivers Letter. As our clients share in the support of these contributions we make, they enable us to help out people like Mr. Sharif and his family. We thank them too.