Report Card Recommendations: 10 Steps to Corporate Social Responsibility
September 10, 2009
- Develop new treatments that offer a significant improvement in the efficacy, safety, tolerability and convenience of existing treatments -- particularly drugs that will work for people who've run out of treatment options, not more "me-too" drugs.
- Engage in truly innovative research including:
a) studying clinically and demographically relevant populations before approval. For instance, differences in drug efficacy, safety, dosing and tolerability by sex, age and race/ethnicity;
b) examining new approaches to treat -- and possibly eradicate -- HIV with immune based therapies rather than focusing solely on antiviral agents;
c) committing to develop and explore new technology that allows for less frequent dosing (once weekly, once monthly);
d) collaborating with other companies on developing drug coformulations as early as possible.
- Consult with the community early in the drug development process to ensure the safety of people with HIV, increase the likelihood of proving efficacy, and to ensure that the greatest amount of information is learned before the drug is approved. History has proved that when companies fail to do this it is often to the detriment of themselves, as well as people with HIV.
- Promptly honor commitments to the Food and Drug Administration (FDA) to broaden the pool of information regarding safety of the drug and its use in different populations -- for instance, women, people of color, and people with other health issues.
- Widen access to the drug as early as safely possible to people who have few other treatment options, while collecting safety and efficacy data in a larger population.
- Provide free drugs, before and after FDA approval, for innovative and necessary additional studies by government and independent researchers.
- Price new drugs at the same level of other drugs in the same class when other such drugs exist -- or -- price drugs such that the overall cost of a treatment regimen does not significantly increase over current regimens.
- Don't hike the price of approved drugs over the cost of inflation.
- Don't engage in negative advertising, which can greatly alarm people with HIV who are on competing drugs. This type of advertising is harmful in general and can have particularly serious consequences for people with HIV, such as stopping their current regimen before speaking with their provider.
- Don't promote the drug for purposes for which it was not approved, and do not positively overstate either efficacy or safety.