Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.
Posted 08 August 2013 | By Alexander Gaffney, RAC,
When it comes to patient groups interacting with the US Food and Drug Administration (FDA), some relationships are more adversarial than others. And while plenty of patient groups have their problems with FDA-its regulatory processes, its standards, its conclusions and its approvals-few do anything to escalate those gripes beyond a letter to the commissioner or a call to their congressperson.
And then there's the AIDS Healthcare Foundation (AHF).
The Washington, DC-based group bills itself as the largest provider of HIV and AIDS medical care in the US, reportedly serving more than 200,000 patients, and has among its goals the generation of new treatments and methods of prevention.
While one of the most prominent patient advocacy groups, the one thing it isn't is a fan of FDA right now.
Focus has written about AHF various times in the past two years, starting with its March 2012 call for FDA Commissioner Margaret Hamburg to resign in response to what it called "the agency's gross mismanagement of new product reviews and a lack of transparency."
"Hamburg's tenure as FDA Commissioner has been marred by questionable product reviews that have ignored scientific evidence, and often FDA's own scientists," wrote AHF in a statement. "Under the leadership of Commissioner Hamburg, the FDA has proven that it cannot be trusted with protecting the American public from unsafe and ineffective drugs."
That statement was specifically prompted by the agency's decision to grant Gilead Science's Truvada, a Pre-Exposure Prophylaxis (PrEP) product, expedited review. The theory behind PrEP products is that by taking medicine prior to risk of exposure-say, protected sexual contact with an HIV-infected partner-a person can vastly reduce, or even eliminate, their risk of contracting the disease, even if the protection (i.e. condom) fails.
Hamburg, for the record, is still at FDA, and the agency never responded publicly to AHF's statement. But the one thing it did do: Extend the review of Truvada by three months in June 2012. At that point, the drug had already overwhelmingly cleared an FDA advisory committee, winning their nod with respect to both un-infected individuals (19-3) and for partnerships in which one person is infected with HIV (19-2, one abstention).
Approximately one month later, FDA announced the approval of Truvada, calling it a "significant regulatory development" and a "milestone in our fight against HIV."
"Every year, about 50,000 US adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease," Hamburg said in a statement released at the time of approval. "New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."
The same day, FDA denied a citizen petition that had been submitted by AHF, which had argued that "grave concerns" about the drug, the studies used to support its approval, and its effectiveness in women should have prompted regulators to deny approval for the drug.
FDA dismissed these arguments, saying some "lack merit" while others were valid, but were simply outweighed by competing beneficial evidence.
"The public health reality is that despite widespread knowledge of HIV/AIDS, decades of intensive condom promotion and availability of antiretroviral drugs to treat HIV infections, the incidence of new HIV infections in the US has remained at a constant level of approximately 50,000 annual HIB infections," FDA explained. "Against this backdrop, the risks posed by Truvada for PrEP that you list… must be balanced against the totality of the data from various clinical trials of oral PrEP."
With few options left, the group turned to its earlier attempts to find out the extent of communications between FDA and Gilead under the theory that the former had unduly aided the latter. The group had already filed Freedom of Information Act (FOIA) requests with FDA in February 2011 to obtain documentation on the regulatory review process.
FDA subsequently denied these requests in part, releasing much of the requested documentation, but redacting part of the safety and efficacy data and data summaries, correspondence, third-party opinions and other internal documents. Consequently, AHF filed a lawsuit against FDA seeking a legal order compelling the agency to turn over the full and un-redacted documents.
And on 7 August 2013, the group announced that it had prevailed in this fight, with the US District Court of Central California ruling that FDA needed to turn over "complete and un-redacted copies of documents" related to Truvada's approval to AHF.
The ruling is of particular interest to regulatory professionals given its treatment of clinical data, largely rebuffing FDA's attempts to withhold data as "trade secrets" or commercial confidential information. FDA, the judge writes in the decision, "does not adduce evidence indicating that there will be actual competition in the PrEP market in the future," and therefore hurt its attempts to illustrate that the release of the information would actually cause harm to Gilead. And because FDA reportedly offered "no other evidence" supporting its assertion of future competition, the court wrote that it disregarded the agency's argument. This result was repeated at several times during the trial, with the judge writing that the court was not persuaded by FDA's arguments that the release of clinical data would harm Gilead, and specifically that it lacked any concrete information to support the contention.
The result: "Because defendants have not demonstrated substantial harm … flowing from the affirmative use of proprietary information, this Court concludes that the information . . . is not confidential information protected from disclosure," and FDA was ordered to hand over all data summaries and analysis generated by Gilead-the same the agency had argued could cause the company competitive harm if used by its competitors.
The redacted correspondence sought by AHF was, however, declared by the court to have been properly withheld as it reportedly expressed incomplete agency views not reflected in the final labeling of the product.
AHF's interpretation of the documents is somewhat more colorful than Judge Margaret Morrow's conclusions, with the group stating that the ruling showed "FDA colluded with Gilead to fast-track approval" and to "conceal unfavorable clinical trial results."
While AHF was silent on what its plans for the information were-or if FDA might appeal the ruling-one thing is nearly certain: Given the history of AHF and FDA, this probably isn't the last we'll hear about Truvada from AHF.
Tags: Clinical Data, Gilead, Truvada, FOIA, Lawsuit
Regulatory Focus newsletters
All the biggest regulatory news and happenings.