Tomorrow, the House Energy and Commerce Subcommittee on Health hears from FDA, industry and consumer advocates about a discussion draft introduced last week that would improve the safety and oversight of the drug supply, and begin to bring foreign standards for drug-making in line with stronger domestic ones.

Earlier this week, I spoke to a supporter of that draft and past efforts to better secure the supply chain. Brant Zell is head of quality and compliance at Rhodia Inc, a chemical maker. He is the past chair of the bulk pharmaceuticals task force for the Society of Chemical Manufacturers and Affiliates, which is a member of the Alliance for a Safe Drug Supply.

I interviewed Zell by phone on the prospects of the drug safety legislation before Congress, the lessons of heparin, and whether the public knows enough about how their drugs are made.

KP: Lawmakers and reporters often talk about the heparin crisis when they talk about a tipping point for the issues in this bill. For you in the chemical manufacturing industry, when did the need to address these issues in a legislative way hit your radar screen?

BZ: I have been working on this since 2002, when I chaired the Bulk Pharmaceutical Task Force, which looks at ensuring both good manufacturing practices (GMPs) and public health and safety.

We filed a citizen petition asking the FDA to take some actions because we saw the risk, we saw the numbers. There has been exponential growth, beginning in 2002 through today,  in foreign API production, and none of it (non-EU) was under the same scrutiny or controls as domestic production. There were no western GMPs in China or India, not many inspections or anything. We also started meeting Congressional staff, and working on draft legislation.

KP: So this is a long time coming for you.

BZ: Oh yes, and well before heparin, which we thought would be the straw that broke the camel’s back. You hate to wait for a heparin incident for that to happen, and even that didn’t change things too much from a legislative point of view. It was a wake-up call for the industry.  The FDA is still working with archaic computer systems, not enough foreign inspectors –it’s a very bleak situation. FDA just has their hands tied, and has had for many years.

KP: Does the public know enough about this issue?

BZ: No. When they do the polls, people are very cautious about buying from countries like China and India, but yet they still buy on price, meaning on some level the general public thinks drugs are safe.  I don’t think they understand the real risk of some of these drugs because there is so little oversight of where their ingredients are made. And of course you don’t know where they are from, since there is no country of origin labeling.  There are some excellent manufacturers in India and China, just the consumer does not know where the drug is made and who the API is being made by.

I think people still buy name brand, and take comfort that the companies are using western standards. But even name brands like Baxter can get stunned because they don’t have enough controls in place to ensure a safe drug was on the market. The public has had a lot thrown at them, and has been desensitized, so you have to wait for another big scare. Unfortunately, I think that’s wrong, and about as un-proactive as you can get.

KP: There have been two drug safety bills introduced in the last two months, The Drug Safety and Accountability Act in August and last week a discussion draft out of Energy and Commerce. Does this represent critical momentum to your mind?

BZ: I wouldn’t say critical, because right now we just have bill introductions. Remember, we had very similar bills in 2009, the Kennedy bill {S. 882} and the Dingell one {Food and Drug Globalization Act of 2009}, and food got split out of that and the drug side was left for potential reintroduction in 2010—now a draft bill.

It’s not critical momentum for me until we have a feeling that something’s going to happen. We have bipartisan support this year. But we had bipartisan support in 2008 and 2009, too. For me, there’s not enough mass/support yet to feel comfortable that the bill will pass.

KP: Let’s talk about the Drug Safety and Accountability Act {S.3690}. When it was introduced by Senator Bennet in August, you said that about 80 percent of the drugs’ active ingredients come from overseas in countries like India and China, but imported drugs receive less than 5 percent of FDA’s resources.  Do you see these bills starting to shift that imbalance?

BZ: You would start seeing a shift. The Dingell draft actually has a very specific requirement for audits to happen, and if they don’t happen, people can’t import. Bennet just gives FDA more authority to mandate more inspections.

KP: So the Dingell discussion draft does a lot of things: increases inspections, requires better notification between companies and the FDA, mandates independent audits, establishes quality systems and supply chain management to ensure the quality and purity of drugs, and gives FDA new authorities, like recall and subpoena. What elements are most critical to SOCMA?

BZ: What’s most critical for SOCMA is a fair and level playing field: that manufacturers abroad operate under similar standards to U.S. manufacturers. It’s also crucial that to give FDA authority so it can do a better job. From a drug supply point of view, I think you have to be careful what you put in the bill, and the enforceability of it. But the Dingell bill is very solid legislation, and would really improve the current situation.

KP: We’ve talked about legislative and regulatory solutions so far. Beyond these two bills, what has the industry done address some of these issues, and what can it do?

BZ: We need good practices in the supply chain, and in the supply purchasing requirements and standards, for everyone: drug, excipient, and API manufacturers. It has to go all the way down the supply chain.

–Kate Petersen, PostScript blogger