FDA Evaded Bidding Process to Hire Public Relations Firm Which Also Works for PhRMA

Last week, the Washington Post reported the unusual - shall we say - way that the US Food and Drug Administration went about setting up a public relations campaign to respond to some negative criticism it has been getting. Here is the background.

The U.S. Food and Drug Administration had an image problem. For months last year the agency had been pummeled by Congress for poor inspections of tainted vegetables, drugs and other products.

FDA leaders decided to hire a contractor for a public relations campaign that would 'create and foster a lasting positive public image of the agency for the American public,' according to agency documents.

How they went about doing this was out of the ordinary.

Tasked with the public relations job was Mildred Cooper, a temporary FDA consultant hired on a two-year contract to advise FDA Commissioner Andrew C. von Eschenbach and other officials. Hired in March, Cooper became an FDA civil servant.

Cooper, who had worked on Capitol Hill and in public affairs for the Federal Emergency Management Agency and Defense Department, called a friend at Qorvis [Communications Inc], which specializes in corporate communications.

Before she joined the FDA, Cooper had worked with Qorvis as a public affairs executive at Luna Innovations, a company that sells medical devices and other products and whose clients include the Defense Department.

'I had experience with Qorvis,' she said in an interview. 'We thought they could help with our communications effort. . . . It was a matter of efficiency.'

She was referred to Don Goldberg, who helps lead Qorvis's crisis communications practice and had once served as part of President Clinton's crisis management team.

Qorvis also represents PhRMA, the drugmakers trade group.

The people involved seemed to have formulated a way to get around the usual government bidding process.

Goldberg discussed the project with [James] Dunn, a business consultant working with Qorvis, e-mails show. They decided to arrange for Qorvis to come into the project through ANI, the Alaska newspaper company, which runs several weeklies and a small public relations office.

Dunn, who works for a firm called Red Team Consulting, told The Post he had experience with the set-aside rules for Alaska Native corporations because he had worked for one as chief operating officer.

ANI, it turns out, is

a firm owned by an Alaska Native corporation that does not have to compete for federal work because it qualifies for special set-asides.

Then,

Other e-mails show that Cooper apparently allowed Qorvis to tailor terms of the contract known as the scope of work.

During most of these discussions, ANI itself was out of the loop.

no one from ANI appeared to be a part of the contract discussions, according to the e-mails. On Feb. 13, Goldberg forwarded a note to Cooper from 'the ANI team contact.' That day, the contact, Washington public relations veteran Aaron Guiterman, wrote to Goldberg, Qorvis and ANI that 'the most likely next step with the FDA is for ANI to submit a proposal.'

In a brief interview, Guiterman said he was not permitted to speak about the contract.

The final result was

On July 23, after more deliberation, the FDA issued a $300,000 purchase order for the public awareness campaign, with ANI listed as the contractor. An FDA official said ANI had pledged in writing to do more than half the work.

Two parts of this are remarkable, of course. One is how a government contract to a big Washington PR firm was arranged without any public bidding or scrutiny. The second was that the company chosen for this contract to improve the image of the FDA, the agency responsible for regulating pharmaceutical companies, went to a firm which also worked for PhRMA, the pharmaceutical industry trade organization. Could this excess coziness of some FDA officials with the pharmaceutical industry, which the agency is supposed to regulate, be evidence of "regulatory capture?" On a policy level, it seems that the US needs to have a much clearer separation between the FDA and the targets of its regulation.

Hat tip to the WSJ Health Blog.

Astroturf Grows in Britain

This is just in case anyone thought this was only an American pheonomenon. As reported by the Independent.

The rising tide of protest over the refusal by the NHS to provide expensive drugs for cancer and other conditions is being funded by the pharmaceutical industry, an investigation by The Independent has revealed.

Patient groups that have been among the most vocal in spearheading attacks on the National Institute for Clinical Excellence (Nice) over decisions to restrict access to drugs on the NHS depend for up to half of their income on drug companies, but details are often undisclosed.

Protests have been launched by charities including the National Kidney Federation, the Arthritis and Musculoskeletal Alliance, the National Rheumatoid Arthritis Society, Beating Bowel Cancer, the Royal National Institute for the Blind and the Alzheimer's Society. All of these charities received sums of up to six figures from drug companies in 2007.

The extent of the drug companies' support for the smaller charities has led to criticisms that supposedly grassroots patient organisations are puppets of the pharmaceutical industry, being used to bludgeon Nice into making the drugs available on the health service.

Yet none of the charities named has criticised the high prices charged by the pharmaceutical companies for their products in their recent campaigns.

The National Kidney Federation (NKF) accused Nice of taking a "barbaric, damaging and unacceptable" decision when it turned down four kidney cancer drugs for NHS use this year and pledged to campaign against the decision. It did not criticise the cost of the drugs, at more than £3,000 for a 30-tablet pack. Half the NKF's £300,000 budget comes from the pharmaceutical and renal industries.

The Arthritis and Musculoskeletal Alliance (Arma) organised a protest letter from 10 professors of rheumatology, published in The Sunday Times last month, over a recent Nice decision to restrict access to arthritis drugs. The letter made no mention of the cost of the drugs but Ros Meek, chief executive, admitted that "half, or more" of the charity's £147,000 income came from the drug industry.

The National Rheumatoid Arthritis Society described the same Nice decision as "another nail in the coffin" for arthritis treatment and launched an appeal against it this week, with Arma and three drug companies. The society received 49 per cent of its £300,000 budget from the pharmaceutical industry in 2005-06, reducing to 26 per cent of its £472,000 budget in 2006-07.

We have heard physicians and leaders of not-for-profit organizations funded by pharmaceutical companies and other commercial health care organizations protest again and again that their activities and decisions are uninfluenced by the source of their money. For example, we recently posted about the President of the US American College of Cardiology who revealed that this medical society receives 38% of its funds from the pharmaceutical industry, but has "firewalls" that prevent this sum of money from having any effect on how the organization operates. Yet, as the saying goes, "he who pays the piper calls the tune."

The current example, from the UK, highlights how organizations that get substantial commercial support never seem to manage to criticize the policies or actions of those who provide the support. One would think a charity devoted to the interests of patients with a particular disease might protest when drug companies charge outrageous prices for treatments for that disease, but as noted above, not one of the charities listed above did so.

So in the absence of transparency, accountability, and clear and enforced codes of ethics, those with health care goods or services to sell are more than happy to plow substantial funds into non-profit, "grassroots" organizations with the not unreasonable hope that such organizations will then promote the requisite marketing or policy agenda. Thus these supposed "grassroots" organizations are really astroturf, and allow their sponsors to engage in stealth health policy advocacy.

Hat tip to Ed Silverman on PharmaLot.