PhRMA revises principles to increase transparency

April 22, 2009

Following calls for increased transparency PhRMA has published its new clinical trial principles, which contain revisions relating to registration, authors and sponsor disclosure.

The pharma industry has been under increasing pressure to become more transparent, with issues such as payments to physicians conducting clinical trials and ghostwriting gaining prominence.

In response the Pharmaceutical Research and Manufacturers of America (PhRMA) has revised its guidelines, which it claims reinforces its “commitment to patients and healthcare professionals”.

PhRMA has made efforts to resolve issues relating to the low publication rate of some clinical trial results, which gained prominence following a paper in PLoS Medicine that found that 17 per cent of Phase I and 43 per cent Phase II to IV studies were published.

The principles also prohibit physicians being paid in stock options but allow investigators to conduct clinical trials for a company that they already have shares in.

A copy of the complete list of principles can be found here .

Source: in-pharmatechnologist

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PhRMA imposes voluntary guidelines on pharma giving

January 7, 2009

These days everyone wants to know exactly what’s passing between pharmaceutical companies and doctors: Down to the cheapest pen, they want to know how doctors might be influenced by pharma. So, to fight the impression that pharma is exerting an undue influence on some or all physicians, Pharmaceutical Research and Manufacturers of America (PhRMA) has introduced new, voluntary guidelines for how pharmaceutical companies deal with physicians.

If they are following the guidelines, pharmaceutical companies will not give out office supplies, clothing or other gifts with logos on them. This lines up with the legislation that several states, including Massachusetts, have passed or considered banning such gifts. The guidelines also prohibit the companies from paying for doctors’ meals.

While dealing with the small amounts involved with these sorts of gifts, though, the guidelines have neglected to deal with the bigger issues of how much physicians are paid by pharmaceutical companies for speaking appearances. These payments have been a major source of controversy for several psychiatrists in recent weeks.

Under the new code:

Pharmaceutical companies are barred from distributing office supplies, clothes and other gifts with company logos or product brand names to physicians and clinics, the Houston Chronicle reports.

The new code also prohibits the companies from paying for physicians’ meals, including those during medical education events, and requires that all grant money allocated for continuing medical education programs be handled by personnel who are not from sales and marketing departments.

The new code does not address the issue of the “amount drugmakers pay doctors to hit the speaking circuit for their products,” according to the Chronicle. The amount has not yet been capped but the companies have been told to keep a record of the consulting fees they pay to each physician (Cook, Houston Chronicle, 1/1).

According to the New York Times, the voluntary moratorium on supplying branded gifts and trinkets to physicians seeks to “counter the impression that gifts to doctors are intended to unduly influence medicine.”

However, while some physicians “applaud the gift ban, others seem offended by the insinuation that a ballpoint pen could turn their heads,” the Times reports, adding that “skeptics deride the voluntary ban as a superficial measure that does nothing to curb the far larger amounts drug companies spend each year on various other efforts to influence physicians” (Singer, New York Times, 12/31/08).

To learn more about the guidelines:

– read this Kaiser Daily Health Policy Report piece


PhRMA releases new direct-to-consumer (DTC) advertising guidelines

December 17, 2008

Five months after updating its Code on Interactions with Healthcare Professionals, the Pharmaceutical Research and Manufacturers of America (PhRMA) released updated guidelines for direct-to-consumer (DTC) advertising.

PhRMA’s Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines, which originally went into effect in January 2006, provide guidance to pharmaceutical research and biotechnology companies on ways to ensure DTC communications provide accurate, accessible, and useful information to patients and consumers.

Click here to read more.


PhRMA Code’s revised guidelines take effect January 2009

July 16, 2008

The Pharmaceutical Research and Manufacturers of America (PhRMA) released updates to its voluntary Code on Interactions with Healthcare Professionals on July 10. The new guidelines take effect January 2009.

In addition to prohibiting small gifts and reminder items, the revised Code:Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations
  1. Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations
  2. Includes new provisions requiring companies to ensure their representatives are sufficiently trained about applicable laws, regulations, and industry codes of practice
  3. Provides that each company will state its intentions to abide by the Code and that company CEOs and compliance officers will certify each year that they have processes in place to comply
  4. Includes more detailed standards regarding the independence of continuing medical education
  5. Provides additional guidance for speaking and consulting arrangements with healthcare professionals
Challenges
  1. Tracking aggregate spending is one of the biggest challenges for pharmaceutical companies
  2. Some companies do not have a system that will accurately record aggregate spending across the organization.
  3. Training employees is another. It’s going to be a challenge getting everyone on the same page.
Benefits
  1. The new guidelines could help the industry regain public trust after “just getting shelled” and constantly being accused of wrongdoing. In addition, some
  2. Companies will be relieved they can reduce their spending on traditional marketing activities.