We are in the midst of summer – hot muggy days that end in thunderstorms around the area and we become aware here in Washington, more than at other times of the year, that we live in a swamp. But don’t worry, next month Congress will adjourn!
Two big stories this week to talk about. The first is to re-cap the news that the FDA is no longer going to issue approvable letters and what that might mean. The second is the issuance by PhRMA of standards for pharmaceutical interactions with physicians:
- FDA to Halt Approvable Letters on August 11 – Curious choice – rather than saying immediately, to say August 11. It makes you wonder if they aren’t going to come out with a few more. What would be the point of that? In any case, yesterday, in case you were out on another planet, the FDA announced that it would no longer be issuing approvable letters in response to new drug applications. Instead, the agency is going to issue Complete Response Letters (CRLs) to let the company know that the PDUFA date has come and the approval has not. The agency will outline steps that the drug sponsor may want to take to try again for approval, but it will then be up to the sponsor to decide if it is worth it to go through those steps – so in many respects, the change of what we call the letter is a matter of semantics in many respects. Approvable letters and non-approval letters have always been proprietary and it is up to a company to say what they will about the contents. For most of us, the difference between the old way and the new may doesn’t mean much and something I did not realize – CRLs have been the way the FDA has responded with biologics out of CBER, they are merely extending this policy now for drugs considered by CDER. Under the old system, we would know when a company received a thumbs down – but one wonders if under the new system, a company could get a CRL that was pretty damning, but they could simply issue a statement saying they were choosing not to carry the application further. It would seem that the new system will add additional questions for investors of the companies they invest in when there isn’t the clarity of a definite non-approval and companies are going to have to consider how they communicate the contents of CRLs. The FDA issued a final rule about the change to Complete Response Letters.
- PhRMA Revised Marketing Code Reinforces Commitment To Responsible Interactions With Healthcare Professionals – Yesterday PhRMA released new guidelines for interactions with healthcare professionals and several pharmaceutical companies issued press releases offering support. The revised code will begin in January 2009 and perhaps there is a desire to quell some of the reform hunger that resides in Congress. The revisions are aimed at further minimizing the appearance of any influence over physician prescribing practices by pharmaceutical marketing methods and (from the press release):
Prohibits distribution of non-educational items (such as pens, mugs and other “reminder” objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, “may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues.”
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. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.
Includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations and industry codes of practice – including this Code – that govern interactions with healthcare professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.
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, a process patterned after the concept of Sarbanes-Oxley compliance mechanisms. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about the companies’ annual certifications of compliance.
Other additions to the Code include more detailed standards regarding the independence of continuing medical education (CME); principles on the responsible use of non-patient identified prescriber data; and additional guidance for speaking and consulting arrangements with healthcare professionals, including disclosure requirements for healthcare providers who are members of committees that set formularies or develop clinical practice guidelines and who also serve as speakers or consultants for a pharmaceutical company.
That’s it for me this week. Have a good weekend everyone.